510k Dental Products and Material

Dental Products and Dental Materials are terms used to describe items and substances used in the field of dentistry for diagnosis, treatment, and maintenance of oral health. Dental Materials are essential for various procedures and treatments in dentistry. They are designed to restore, replace, and maintain the health and function of teeth.

It is important to find out the device code for 510k exempted and 510k required products. Refer table provided below for easy reference.

• Preventive dental materials: Preventive dental materials like sealants, restoratives, toothpaste, gels, mouthwashes, liners, and bases prevent dental disease by modifying microbial growth sites and releasing therapeutic agents like fluoride or chlorhexidine.
• Restorative dental materials: Restorative dental materials replace or repair missing dental tissues, including, amalgam, bonding agents, resin-based composite, cement base and dental polymers. They can be temporary or permanent, used for temporary or long-term applications.
• Direct Restorative Materials: The direct restorative materials are manipulated in the dental clinic for their final application and include dental Amalgam and dental cement.
• Indirect Restorative Materials: The indirect restorative materials are prepared for their final application in a dental laboratory by a dental technologist or a technician. The indirect restorative materials include porcelain fused to metal restorations used for crown and bridge construction, metal alloys, and polymers that are used for the construction of complete and partial dentures.
• Impression Materials: Impression materials are substances used in dentistry to create a negative replica or mould of the teeth, gums, and surrounding oral tissues. These moulds are then used to produce accurate models or casts, which are essential for various dental procedures such as creating crowns, bridges, dentures, and orthodontic devices. Example: Alginate, Polyvinyl Siloxane (PVS)
• Dental cement: Materials used in dentistry for a variety of purposes, including luting (cementing) crowns, bridges, inlays, and orthodontic appliances, as well as serving as bases, liners, or temporary fillings. They play a crucial role in the success and longevity of dental restorations and treatments. Example: Zinc Phosphate Cement, Resin Cement
• Bonding Agents: Adhesive Systems: Used to bond dental materials to the tooth structure, such as composite resins to enamel
• Endodontic Materials: Root Canal Fillers: Materials like gutta-percha are used to fill and seal the root canals after a root canal treatment.
• Sealants: Materials used to seal the access points in root canal therapy.

Cement, dental: It is available as glass-ionomer luting cement and self-adhesive luting cement

Glass-ionomer luting cement: It is a glass-ionomer luting cement in the form of powder and liquid. This glass-ionomer cement is easy to handle and provides adhesion to hard dental tissues.

Intended Use: This device is intended to serve as a temporary tooth filling or as a base cement to affix a temporary tooth filling, to affix dental devices such as crowns or bridges, or to be applied to a tooth to protect the tooth pulp.

Description of Device: It is the ideal radiopaque, self-curing translucent, particle glass-ionomer luting material with excellent tooth adhesion high fluoride release, and flowability, it is useful for a wide range of clinical applications.

Key Features:

1. Advanced Glass Ionomer Technology:It incorporates advanced glass ionomer technology, offering a unique combination of biocompatibility and fluoride release. This technology contributes to the long-term health of the restored tooth and surrounding structures.
2. Quick and Easy Mixing:The cement features a user-friendly mixing process, ensuring a quick and homogenous mix for hassle-free application. This ease of use enhances the overall efficiency of the luting procedure, making it suitable for a variety of restorative applications.
3. Dual-Cure Capability:It exhibits dual-cure capability, providing flexibility in cementation procedures. Whether activated by light curing or self-cured, this feature ensures reliable and thorough polymerization, even in areas with limited light exposure.

Benefits:

1. Biocompatibility and Fluoride Release:It is a glass ionomer formulation that ensures biocompatibility with tooth structures while releasing fluoride over time. This dual benefit supports the restoration’s integration with the natural dentition and contributes to the prevention of secondary caries.
2. Versatile Clinical Applications:Suitable for a wide range of clinical applications, Ace-Cem is ideal for the cementation of crowns, bridges, inlays, on-lays, and orthodontic bands. Its versatility makes it a valuable tool for practitioners addressing various restorative challenges.
3. Consistent and Durable Bond: The cement establishes a consistent and durable bond between restorations and tooth structures. This bond strength is vital for the long-term success and stability of luted restorations, ensuring patient satisfaction and oral health.

Self-adhesive luting cement:

It is a dual-cured self-adhesive resin cement that requires no pre-treatment. This material shows high bonding strength on various prosthesis in Zirconia, Metal, Composite resin, Glass-ceramic, and no micro-leakage. Also, it is easy to use and remove excess cement. It has better physical properties in compressive strength, flexural strength, and film thickness with good radiopaque. Shade ranges are Clear, Universal, and Opaque.

Intended Use: Cementation of ceramic, metal, or composite inlays, on lays, crowns, bridges, and posts.

Device Description:

• The description often details the chemical composition of the dental cement, including the active ingredients and any additives.
• The device description may explain how the dental cement works, such as its adhesive properties, curing mechanisms (e.g., self-curing, light-curing), and how it interacts with tooth structures.
• Details about the form in which the cement is provided, like powder and liquid, pre-mixed paste, or capsules, and the packaging size or type.
• The intended use of dental cement is specified, such as for bonding crowns, bridges, inlays, onlays, or orthodontic appliances. It might also include applications like temporary or permanent fillings.

Features & Benefits:

• Uniform luting cementation
• Continuous fluoride ion release effect
• Easy removal & easy handling
• Available in all cases of cementation
• Powerful bonding strength
• Satisfaction of the ISO 13485 requirements

Zinc oxide Eugenol

Eugenol is used as an obtundent for the relief of minor dental pain and as a sedative during dentinal dressing when combined with zinc oxide.

Intended Use: This device is intended for temporary relief of localized dental pain, may be combined with zinc oxide to form a sedative dressing.

Description of Device:

• Eugenol reacts with zinc oxide to form a sedative dental dressing or lining under a non-composite resin restoration. 3 years from the date of Manufacturing. pure eugenol oil is used for the relief of insignificant dental pain and also to form sedative dentinal dressing with zinc oxide. Eugenol is widely employed in medicine because of antibacterial.
• Eugenol has been widely used in dentistry to treat toothache and pulpitis.
• A previous study indicated that eugenol may be an ideal natural agent for use in oral care products.
• Clove oil contains the active ingredient eugenol, which is a natural anaesthetic. It helps numb and reduce pain to ease a toothache.
• Eugenol also has natural anti-inflammatory properties. It may reduce swelling and irritation in the affected area.

Benefits:

• Forms a sedative dressing or lining under non composite resin when mixed with Zinc Oxide
• Chemically pure with increased effectiveness
• Forms a uniform paste consistency when mixed with Zinc Oxide

Dental cement w/out zinc-oxide eugenol as an ulcer covering for pain relief

Intended use: It creates a thin, protective barrier that provides immediate and long-lasting relief of pain associated with canker sores, mouth sores, and traumatic ulcers, such as those caused by braces.

Description of Device: It is a non-zinc-oxide eugenol dental cement formulated specifically for oral ulcer management. It is designed to be applied directly to the ulcerated area in the mouth, forming a protective coating that isolates the ulcer from external irritants and provides temporary pain relief.

Composition: It consists of the following essential components:

• Base Material: A blend of resins or polymers chosen for their biocompatibility and adhesive qualities, ensuring strong adhesion to oral tissues and long-lasting durability.
• Filler Agents: Inert substances that improve the cement’s mechanical properties, including its consistency and strength.
• Setting Agents: Compounds that allow the cement to cure and solidify within a clinically acceptable period.

cement, ear, nose, and throat

Intended use: It is indicated for use in the following applications:

1. Augmentation or coupling of the middle car ossicles.
2. Attachment of the middle ear ossicles to middle ear implants.
3. Mechanical stabilization of middle ear prostheses.
4. Reconstruction of the posterior canal wall.

Description of Device:

• It’s a customized applicator made to administer dental cement precisely during endoscopic treatments. To guarantee appropriate adhesion and stability during ENT therapies involving the oral and maxillofacial regions, dental cement or similar materials are applied.
• The device operates by loading dental cement into the chamber and engaging the delivery mechanism to apply the cement. It allows for precise application and secure placement of dental materials or prostheses in ENT procedures.

Key Components/ Features:

• Applicator Handle: Stainless steel or medical-grade plastic, this ergonomically designed handle allows for precise control and a comfortable grip.
• Cement Delivery System: Contains a pump mechanism or syringe-based system for delivering dental cement. The material application and flow are regulated by the delivery system.
• Nozzle/Tip: Equipped with a fixed tip or an interchangeable nozzle, this part allows for precise cement placement. Constructed from materials, such as silicone or stainless steel, and offered in diverse sizes to suit a range of uses.
• Cement Chamber: A section intended to contain dental cement that can hold a specific volume, e.g., 5 cc of material while guaranteeing a steady supply.

A resin tooth bonding agent is a device material, such as methyl methacrylate, intended to be painted on the interior of a prepared cavity of a tooth to improve retention of a restoration, such as a filling.

Intended Use: Direct restorations using light-cured composite resin, Sealing of a prepared cavity or abutment tooth as a pretreatment for indirect restorations, Treatment of exposed root surfaces and hypersensitive teeth, Intraoral repairs of fractured restorations, Post cementation and core build-ups, Cementation of indirect restorations.

Description of Device:

• It is a high-quality dental etchant solution meticulously designed to enhance enamel and dentin surface preparation for various dental procedures. It offers practitioners a reliable tool for achieving optimal bonding and restorative outcomes.
• Rinses off easily and cleanly, leaving an easy-to-read frosty appearance on the enamel surface indicating it is ready for the bonding agent application.

light-cure bonding agent that allows for the treatment of dentin, enamel, and prosthetic materials.

• It selectively removes the surface layer of materials such as glass ceramics, feldspathic porcelain, and certain metals, creating a roughened texture that enhances the bond strength between the substrate and dental restoratives like composite resins or bonding agents.

Benefits:

• Permanent, aesthetic repairs Easy and time-saving application
• No removal or re-cementation of crowns and bridges, no necessity of impressions
• Efficient and Controlled Etching
• Consistent Clinical Performance
• Easy cleaning and removal

Material, Tooth Shade, Resin

Restorative Instrument and Component Tray

Tooth shade resin material is a device composed of materials such as bisphenol-A glycidyl methacrylate (Bis-GMA) intended to restore carious lesions or structural defects in teeth.

Intended Use: This device is intended to restore carious lesions or structural defects in teeth.

Description of Device:

• It is a Bis-GMA-based restorative composite. It is designed for restorations in anterior and posterior teeth and is suitable for occlusal surfaces. Its formula contains a zirconia/silica inorganic filler combination and barium glass.
• It is available in various forms such as restorative Glass Ionomer Cement (GIC) sets a new standard in restorative dentistry, providing a versatile and reliable solution for a range of clinical applications, is available as a kit that represents a comprehensive and advanced solution for restorative dentistry, combining cutting-edge technology with ease of use and It is a flowable composite resin to offer a low viscosity, which allows it to flow easily into cavities and intricate areas for precise and effective coverage.

Key Features:

• High-strength Radiopaque glass ionomer Restorative
• High-strength strontium-based Glass ionomer restorative
• User friendly
• Making it an indispensable choice for direct restorations.

Benefits:

1. Aesthetic Excellence
2. Versatile Clinical Application
3. Efficient Workflow
4. Universal for all cavity classes
5. Durable and long-lasting fillings
6. Packable consistency Sticks to the cavity not to the instrument
7. Excellent adhesion to tooth substance
8. Superior physical properties

It is a calcium hydroxide-based paste designed to provide practitioners with an effective tool for pulp capping, apexification, and other endodontic procedures.

Intended Use: This device is to be applied to the interior of a prepared cavity before the insertion of restorative material, such as amalgam, to protect the pulp of a tooth.

Description of Device:It is useful in pulp capping and as a protective base/liner under dental filling materials, cements other base materials.

Key Features:

• Time-saving, direct application, and light curing.
• Ready to use one component material.
• Acid Resistant.
• Effective protection of the pulp.
• Helps formation of secondary dentine.
• Excellent adhesion to composites.
• High compressive strength.
• Low solubility in oral fluids.

 Indication:

• For indirect pulp capping.
• Acid protection when applying the etch technique.
• As cavity liner under all filling materials.

Benefits:

• Higher compressive strength than conventional calcium hydroxides
• Excellent adhesion, especially to composites
• Effective protection of the pulp
• Acid resistant
• Radiopaque
• Ready-to-use: no mixing, no bubbles

Resin, Root Canal Filling

Endodontic Kit

Resin, Root Canal Filling Containing Chloroform

It is a premixed root canal-filling material. A root canal-filling resin is a device composed of material, such as methyl methacrylate.

Intended Use: It is intended for use during endodontic therapy to fill the root canal of a tooth.

Description of Device: It has excellent radiopacity and is ideal for many endodontic applications. It is used to provide practitioners with an effective tool for pulp capping, apexification, and other endodontic procedures.

Key Features:

• High Purity Calcium Hydroxide: a well-established material in endodontics known for its antimicrobial properties and ability to stimulate dentinogenesis. The high-quality formulation ensures the delivery of therapeutic benefits associated with calcium hydroxide.
• Optimal Radiopacity: The material exhibits optimal radiopacity, enhancing visibility on dental radiographs. This feature allows for accurate assessment of the placement, supporting precise treatment planning and evaluation.
• Syringe Delivery System: It is conveniently delivered through a syringe system, allowing for controlled dispensing of the paste. This syringe delivery system enhances the precision and ease of application, especially in challenging anatomical situations.
• Versatile Clinical Applications: It is suitable for a range of clinical applications, including pulp capping, apexification, and the treatment of root resorption. Its versatility makes it a valuable tool in endodontic practices.

Applications:

• Exposed pulp in pulp capping and pulpotomy Leakage canal
• Apexification (Formation of hard tissue barrier) Root canal filling material
• Root canal filling for deciduous teeth
• Internal and external root resorption

 Benefits:

• Easy cleaning and removal
• Excellent antibacterial effect and radiopacity
• Time-saving direct application

A liquid chemical sterilant/high-level disinfectant is a germicide that is intended for use as the terminal step in processing critical and semi-critical medical devices before patient use. Critical devices contact normally sterile tissue or body spaces during use. Semi-critical devices make contact during use with mucous membranes or nonintact skin. 

Intended use: Intended for liquid chemical sterilization of cleaned, immersible, and reusable semi-critical heat-sensitive medical devices and their accessories in healthcare facilities.

Device Description:

• It is a chemical solution used for the cold sterilization of medical and dental instruments. It is formulated to provide high-level disinfection by inactivating bacteria, viruses, fungi, and spores on surfaces and instruments. The solution is intended for use in healthcare facilities to ensure the safety and cleanliness of reusable devices.
• It shows germicidal action via a strong oxidation reaction of cellular components. May be used for sterilizing deep cavities.

Key Components:

1. Active Ingredients: The solution is formulated with key antimicrobial agents, such as glutaraldehyde, ortho-phthalaldehyde (OPA), and hydrogen peroxide, which are essential for achieving high-level disinfection.
2. Inactive Ingredients: The formulation may also contain additional components, including stabilizers, surfactants, and solvents, which contribute to the solution’s effectiveness and stability.
3. Packaging: The solution is available in various forms, such as bottles, drums, or pre-measured containers. Each package includes detailed labelling with usage instructions, concentration, and safety information.

Impression material is a device composed of materials such as alginate or polysulfide intended to be placed on a preformed impression tray and used to reproduce the structure of a patient’s teeth and gums.

Intended use: The device is intended to provide models for study and for the production of restorative prosthetic devices, such as gold inlays and dentures.

Device Description:

• It is used by dentists to obtain anatomical data of the patient’s mouth and then to obtain a useful plaster cast to diagnose problems, identify necessary interventions, and/or check their effectiveness.
• They are elastomeric materials with hydrophilic properties, high tear strength, dimensional accuracy, and resistance to permanent deformation, cured by addition reaction.

Crown And Bridge, Temporary, Resin

Crown And Bridge, Long-Term Temporary, Resin

A temporary crown and bridge resin is a device composed of a material, such as polymethylmethacrylate, intended to make a temporary prosthesis, such as a crown or bridge, for use until a permanent restoration is fabricated.

Intended use: Temporary restoration

Device Description: According to the instructions for use, it can be used by the dental technician to manufacture permanent crowns, bridges, and denture frameworks.

Intended use: For the fabrication of preformed denture teeth for use in a denture base Resin.

Device Description:

The digital patient scan is used in conjunction with software and a 3D printer to build patient-matched denture teeth by depositing layer upon layer of the resin material.

Intended use: Subperiosteal implant material is a device composed of titanium or cobalt chrome molybdenum intended to construct custom prosthetic devices which are surgically implanted into the lower or upper jaw between the periosteum (connective tissue covering the bone) and supporting bony structures. The device is intended to provide support for prostheses, such as dentures.

Device Description:

• It is a subperiosteal implant placed beneath the periosteum to support dental prostheses, providing a stable base for crowns or bridges while integrating with surrounding tissues for functional and aesthetic restoration.
• It is placed under the periosteum to provide a stable base for dental prostheses, integrating with surrounding tissues for reliable, long-lasting support.

Key Components:

• Material Composition: Titanium, titanium alloy, or other biocompatible materials are used to make the device. These materials were selected due to their strength, resilience, and suitability for both soft tissue and bone.
• The implant’s design features include things like a customized shape that fits the patient’s jawbone and ridges or perforations that improve tissue integration.
• Packaging: Each box containing the subperiosteal implant’s specifications and management guidelines is labeled. Examples of these packages include sterile pouches or containers.

It is a device composed of polytetrafluoroethylene (PTFE) vitreous carbon.

Intended use: It is intended for use in maxillofacial alveolar ridge augmentation (building up the upper or lower jaw area that contains the sockets in which teeth are rooted) or intended to coat metal surgical implants to be placed in the alveoli (sockets in which the teeth are rooted) or the temporomandibular joints (the joint between the upper and lower jaws).

 Device Description:

• It combines PTFE and vitreous carbon to offer a robust, chemically resistant, and biocompatible solution for various medical applications.
• It provides a durable, chemically resistant surface for implants or grafts, with PTFE offering flexibility and vitreous carbon providing structural support. It integrates with surrounding tissues for reliable long-term performance.

Key Components:

• Polytetrafluoroethylene (PTFE): A fluoropolymer with outstanding chemical resistance, low friction, and non-reactivity, enhancing the device’s durability and compatibility with bodily fluids.
• Vitreous Carbon: A high-strength, high-temperature material with superior chemical inertness and minimal surface reactivity, which improves the device’s structural integrity and longevity.
• Combination Properties: The combination of PTFE and vitreous carbon creates a synergistic effect, offering enhanced strength, chemical resistance, and biocompatibility for optimal performance.

Bone grafting material includes hydroxyapatite, tricalcium phosphate, polylactic and polyglycolic acids, or collagen that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Barrier, Synthetic, Intraoral

Intended use: A synthetic dental barrier is a synthetic material device, such as PTFE, intended to aid in guided tissue and/or bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials.

Barrier, Animal Source, Intraoral

Intended use: An animal-source dental barrier is an animal-derived material device, such as collagen. It is intended to aid in guided tissue/bone regeneration procedures and to act as a stable barrier for the containment of bone graft materials when placed around implants.

Bone Grafting Material, For Dental Bone Repair

Intended use: It is Tricalcium phosphate bone grafting material that is intended to fill, augment, or reconstruct periodontal or bony defects of the oral and maxillofacial region.

Bone Grafting Material, Synthetic

Intended use: A synthetic bone grafting material is a synthetically derived device, such as hydroxylapatite, intended to fill, augment, or reconstruct periodontal and or bony defects of the upper or lower jaw.

Bone Grafting Material, Synthetic

Intended use: An animal-source bone grafting material is a naturally derived device, such as collagen, intended to fill, augment, or reconstruct periodontal defects and or bony defects of the upper or lower jaw.

Bone Grafting Material, Human Source

Intended use: It is intended to be packed into bony voids or gaps to fill and/or augment dental intraosseous, oral and cranio-/maxillofacial defects. these defects may be surgically created osseous defects or osseous defects created from traumatic injury to the bone, including periodontal/intrabody defects; alveolar ridge augmentation (sinusotomy, osteotomy, cystectomy); dental extraction sites (ridge maintenance, implant preparation/placement); sinus lifts; cystic defects; craniofacial augmentation.

Bone Grafting Material, Dental, With Biologic Component

Intended use: Dental bone grafting material with growth factors is a combination product that consists of a bone grafting material that contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.

Biologic Material, Dental

Intended use: Other dental material with growth factors is a material, used with or without other devices, which contains biologic or drug components, such as proteins, that are intended to stimulate and/or inhibit the growth of certain tissues of the oral and maxillofacial region.

 Device description:

• It is a biocompatible bone grafting material specifically designed for dental applications. It supports bone healing and regeneration by filling bone defects and providing a scaffold for new bone growth.
• It is applied to dental bone defects or voids during surgical procedures. It serves as a scaffold to support and enhance the natural bone healing process. The material integrates with the surrounding bone, encouraging new bone growth and repair.

Key Components:

• Material Composition: It is made from such as synthetic hydroxyapatite, demineralized bone matrix, or natural bone-derived materials, selected for its bone tissue compatibility and ability to promote new bone growth.
• Form: It is offered in granules, blocks, putty, or pastes to simplify application during dental procedures.
• Packaging: It comes in sterile single-use containers or vials to ensure sterility and ease of handling.

Intended use: Dental amalgam is a device that consists of a combination of elemental mercury, supplied as a liquid in bulk, sachet, or predosed capsule form, and amalgam alloy composed primarily of silver, tin, and copper, supplied as a powder in bulk, tablet, or predosed capsule form, for the direct filling of carious lesions or structural defects in teeth. This device also includes the individual component devices, mercury and amalgam alloy, when intended to be combined with each other to form dental amalgam.

Device description:

• A dental amalgam is a device that consists of a metallic alloy, such as silver, tin, copper, and zinc, that is mixed with liquid elemental mercury for the direct filling of carious lesions or structural defects in teeth.
• Powder and liquid metals are encapsulated and separated by a septum. Forms a solid upon mixing.
• A heterogeneous mixture of alloy and elemental mercury hardens to form a solid that is used as a direct filling material.

Intended use: A denture relining, repairing, or rebasing resin is a device composed of materials such as methyl methacrylate, intended to reline a denture surface that contacts tissue, repair a fractured denture, or form a new denture base. This device is not available for over-the-counter (OTC) use.

Device description: It is supplied as components in powder and liquid form. The powder is primarily a polymer of polymethyl methacrylate (PMMA) with small quantities of initiator and colour pigments. The liquid is primarily the monomer methyl methacrylate (MMA) with small quantities of a cross-linking agent and activator. To fabricate the denture base, the powder and liquid materials are mixed and stirred to create a dough state that is packed or poured into a mould, saddle, or core. The resin then cures in a self-curing process (pressure vessel or via quick-setting).

Intended use: A coating material for resin fillings is a device intended to be applied to the surface of a restorative resin dental filling to attain a smooth, glaze-like finish on the surface of the filling.

Device description: The light-curing one-component dental sealing lacquers are designed for coating resin parts of complete and partial dental prostheses and for provisional crowns and bridges. The lacquer is applied to a dental restoration and cured with the help of a dental light-curing unit.

Intended use: A hydrophilic resin coating for dentures is a device that consists of a water-retaining polymer that is intended to be applied to the base of a denture before the denture is inserted into the patient’s mouth to improve denture retention and comfort.

Device description: It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

A pit and fissure sealant and conditioner is a device composed of resin, such as polymethyl methacrylate, intended for use primarily in young children to seal pit and fissure depressions (faults in the enamel) in the biting surfaces of teeth to prevent cavities.

Intended use: intended to seal pit and fissure depressions/faults in the enamel, and in the biting surfaces of teeth. For dental professional use only.

Device Description: Pit and Fissure sealants are used as a preventive measure to fill defects and prevent decay within crevices, voids or fissures on the surface of teeth. These voids are more challenging to keep free of substances that can lead to caries and eventual breakdown of tooth structure. BA Pit & Fissure Sealant is a material designed to fill these voids with a wear-resistant material, ultimately preserving natural tooth structure.

Intended use: It is intended for use in Creating attachments for orthodontic tray aligners and Bonding orthodontic brackets to teeth.

Device description:

• It is a resin-based adhesive designed for use in orthodontics. It conditions the tooth surface and provides a secure bond for attaching brackets, improving the effectiveness of orthodontic treatments.
• It is designed to be used in conjunction with other orthodontic components to achieve optimal results.

Key Components:

• Adhesive Composition: It contains resin, bonding agents, and fillers formulated to ensure strong adhesion and compatibility with tooth enamel and orthodontic brackets.
• Formulation: It is available as gel, paste, or liquid to facilitate easy application and uniform coverage.
• Packaging: It is packaged in syringes, bottles, or single-use vials to maintain sterility and ensure precise application.

Intended use: It dissolves and removes dental cement and adhesives from teeth, prosthetics, and surfaces, aiding in the clean removal of residual cement after treatments.

Device Description: It is a chemical solution designed to dissolve dental cement and adhesives, ensuring a clean, residue-free surface for further treatment or restoration.

It is designed to be used in dental practices and medical settings to ensure effective cleaning and preparation of surfaces for subsequent procedures.

Key Components:

• Active Ingredients: It may contain key components such as phosphoric acid, citric acid, or other acidic agents known for their ability to break down cement materials.
• Inactive Ingredients: These include other substances such as surfactants, stabilizers, or solvents to enhance the solution’s effectiveness and stability.
• Formulation: It is available in liquid solution, or gel form for easy application and control.

Intended Use: An oral cavity abrasive polishing agent is a device in paste or powder form that contains an abrasive material, such as silica pumice, intended to remove debris from the teeth. The abrasive polish is applied to the teeth by a handpiece attachment (prophylaxis cup).

Device Description:

• Description of the type of abrasive particles used, such as pumice, silica, aluminium oxide, or other material
• Information on any binders, fillers, or additives included in the formulation, which might affect texture, viscosity, or other properties.
• The substance in which the abrasive particles are suspended, such as water, glycerin, or other carriers.
• The specific use of the abrasive polishing agent, such as polishing teeth, dental restorations, or dental appliances. It might specify whether the product is for professional dental use or consumer over-the-counter (OTC) use.
• Identification of the type of surfaces it is intended for, such as enamel, dentin, composite restorations, or metal restorations.
• Description of how the abrasive agent works to polish surfaces by mechanically removing stains, plaque, or surface irregularities.
• Information on the size of the abrasive particles influences the level of abrasiveness and the smoothness of the finish.
• The physical form of the product, such as paste, powder, or slurry.
• Information about packaging, such as tubes, jars, or single-use packets, including the volume or weight of the product.
• It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

Intended Use: Resin impression tray material is intended for use in a two-step dental mould fabricating process.

Device Description:

• The device consists of a resin material, such as methyl methacrylate, and is used to form a custom impression tray for use in cases in which a preformed impression tray is not suitable, such as the fabrication of crowns, bridges, or full dentures. A preliminary plaster or stone model of the patient’s teeth and gums is made.
• The resin impression tray material is applied to this preliminary study model to form a custom tray. This tray is then filled with impression material and inserted into the patient’s mouth to make an impression, from which a final, more precise, model of the patient’s mouth is cast.
• It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

Intended Use: A dental hand instrument is a hand-held device intended to perform various tasks in general dentistry and oral surgery procedures.

Device Description:

• The device includes the operative burnisher, operative amalgam carrier, operative dental amalgam carver, surgical bone chisel, operative amalgam and foil condenser, endodontic curette, operative curette, periodontic curette, surgical curette, dental surgical elevator, operative dental excavator, operative explorer surgical bone file, operative margin finishing file, periodontic file, periodontic probe, surgical rongeur forceps, surgical tooth extractor forceps, surgical hemostat, periodontic hoe, operative matrix contouring instrument, operative cutting instrument, operative margin finishing periodontic knife, periodontic marker, operative pliers, endodontic root canal plugger, endodontic root canal preparer, surgical biopsy punch, endodontic pulp canal reamer, crown remover, periodontic scaler, collar and crown scissors, endodontic pulp canal filling material spreader, surgical osteotome chisel, endodontic broach, dental wax carver, endodontic pulp canal file, hand instrument for calculus removal, dental depth gauge instrument, plastic dental filling instrument, dental instrument handle, surgical tissue scissors, mouth mirror, orthodontic band driver, orthodontic band pusher, orthodontic band setter, orthodontic bracket aligner, orthodontic pliers, orthodontic ligature tucking instrument, forceps, for articulation paper, forceps for dental dressing, dental matrix band, matrix retainer, dental retractor, dental retractor accessories, periodontic or endodontic irrigating syringe, and restorative or impression material syringe.
• If the device is made of the same materials that were used in the device before May 28, 1976, it is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.

Intended Use: An anaesthetic warmer is an AC-powered device into which tubes containing an anaesthetic solution are intended to be placed to warm them before administration of the anaesthetic.

Device Description:

• The device is intended to warm composite materials before use.
• It contains an apparatus with a heating base and dispenser.
• Compules of composite resin are heated by a heating element. When the desired temperature is reached, a dispenser is used to deliver warmed composite resin to the patient.
• The device is supposed to be used for areas like Heated externally for intraoral use.
• It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

Intended Use: A resin applicator is a brushlike device intended for use in spreading dental resin on a tooth during the application of tooth shade material.

Device Description:

• It is a specialized dental tool for precise application and handling of resin materials, ensuring accurate placement and shaping during restorative procedures.
• The device is designed to ensure efficient and effective application, contributing to high-quality restorative outcomes.
• It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

Intended Use: An orthodontic appliance and accessories is a device intended for use in orthodontic treatment.

Device Description:

• It is a specialized dental tool for precise application and handling of resin materials, ensuring accurate placement and shaping during restorative procedures.
• The device is affixed to a tooth so that pressure can be exerted on the teeth. This device includes the preformed orthodontic band, orthodontic band material, orthodontic elastic band, orthodontic metal bracket, orthodontic wire clamp, preformed orthodontic space maintainer, orthodontic expansion screw retainer, orthodontic spring, orthodontic tube, and orthodontic wire.
• It is a 510k exempt device so, this dental product is not required to undergo 510k submission.

Intended use: Irrigating solution that cleanses the root canal system by removing the smear layer after endodontic instrumentation. In addition, The cleanser is used to clean and disinfect the root canal system by removing debris, bacteria, and necrotic tissue. This is crucial for preventing infections and promoting healing.

Device Description:

• A brief description of the device and its purpose in root canal treatment
• A list of all the parts included in the device package, such as the syringe, needle or cannula, and any other attachments or accessories.
• Information about the materials used to manufacture each component (e.g., plastic, stainless steel, medical-grade polymers)
• Description of the packaging materials and how the device is packed to maintain sterility.
• Detailed instructions on how to use the device during the root canal procedure, including recommended techniques for irrigation.
• Guidelines for safe disposal of the device after use, especially if it is single use.
• Steps for preparing the device before use, including attaching the needle to the syringe and filling it with the irritant.
• Detailed instructions on how to use the device during the root canal procedure, including recommended techniques for irrigation

Intended Use: Retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate for the temporary gingival retraction and hemostasis of the gingival margin.

Device Description: It is a non-impregnated knitted retraction cord made from 100% cotton. It is a knitted retraction cord made from 100% cotton, impregnated with Aluminum Chloride Hexahydrate.

Intended Use of Restoration, Resin, Crown And Bridge and Crown: It is intended for use in restorative dental procedures to fabricate and repair dental crowns and bridges. The resin-based material is designed to provide durable, aesthetic restorations that restore the function and appearance of natural teeth.

Intended Use of Crown and bridge material resin-based: It is used for dental crown restorations by a single crown, bridge, etc, or for the indirect repair of dental crown fabrications.

Device Description:

• Foreign dental lab-manufactured resin crown and bridge restorations are crown and bridge restorations that are manufactured as finished products from resins.
• It is a dental resin composite designed to create and repair crowns and bridges. It is formulated to provide both high strength and aesthetic similarity to natural teeth. This product is ideal for various therapeutic procedures where durability and a natural appearance are essential.
• It is utilized to prepare and fabricate dental crowns and bridges. The resin composite is applied to the tooth surface or mould and then cured with a light source or through a chemical reaction. The properties of the material ensure that the resulting crowns and bridges are robust, long-lasting, and aesthetically similar to natural teeth.

Key Components:

• Resin Composite Material: The device consists of a resin-based composite that incorporates [list main components, e.g., methacrylate resins, silica fillers, and colour pigments]. This formulation delivers the required strength, longevity, and colour-matching capabilities to blend seamlessly with natural teeth.
• Shade Range: Available in a variety of shades, such as [e.g., A1, A2, A3, B1, B2], the resin allows for precise colour matching to natural teeth.
• Packaging: The resin composite is offered in [e.g., syringes, jars, or capsules], with each package clearly labelled with the specific shade and usage instructions.

Intended Use: It is intended for use in dental restorative procedures to repair and rehabilitate damaged or decayed teeth. This resin-based composite offers a robust and aesthetically pleasing solution, effectively restoring both the function and appearance of the tooth.

Device Description:

• Foreign dental lab-manufactured resin restorations are permanent restorations that are manufactured as finished products from resins.
• It is a dental resin composite material designed for various restorative procedures. It is crafted to provide both high strength and a natural-looking appearance, effectively imitating the structure of natural teeth. This product is ideal for use in dental fillings, repairs, and other restorative treatments where both durability and aesthetic quality are essential.
• It is applied to the prepared tooth and then cured, restoring its structure and function. The resin composite creates a durable, natural-looking repair.

 Key Components:

• Resin Composite Material: The device consists of a resin-based composite that incorporates [list main components, e.g., methacrylate resins, silica fillers, and colour pigments]. This formulation delivers the required strength, longevity, and colour-matching capabilities to blend seamlessly with natural teeth.
• Shade Range: Available in a variety of shades, such as [e.g., A1, A2, A3, B1, B2], the resin allows for precise colour matching to natural teeth.
• Packaging: The resin composite is offered in [e.g., syringes, jars, or capsules], with each package clearly labelled with the specific shade and usage instructions.