Prime-Dent Chemical Cure Composite Restorative Material
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994224 FDA 510(k)
- FDA Product Code
- EBF FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3690 FDA 510(k)
- Regulation Number
- 872.3690 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Prime-Dent Chemical Cure Composite Restorative Material is a dental composite resin classified under the nomenclature category for dental restorative materials. It is designed to restore damaged or decayed teeth by filling cavities and providing structural integrity through chemical curing, ensuring durable and aesthetically pleasing results.
This material is supplied as a single-use, non-sterile dental filling product intended for use in clinical settings by dental professionals. It is regulated under FDA 510K clearance, MDD, and MDR compliance, with a product code of EBF. Storage conditions and handling must adhere to manufacturer guidelines to maintain product integrity.
Frequently asked questions
What types of dental damage is the Prime-Dent Chemical Cure Composite Restorative Material intended to address in clinical practice?
The Prime-Dent Chemical Cure Composite Restorative Material is designed to restore damaged or decayed teeth by filling cavities. It provides structural integrity through chemical curing, making it suitable for repairing areas affected by caries or minor structural defects where a durable, aesthetically pleasing filling is required.
Is the Prime-Dent Chemical Cure Composite Restorative Material intended for single-use only, and if so, why?
Yes, the Prime-Dent Chemical Cure Composite Restorative Material is supplied as a single-use product. This is because dental composites are typically formulated for one-time clinical application to ensure sterility and prevent cross-contamination between patients, even though the material itself is non-sterile.
How should the Prime-Dent Chemical Cure Composite Restorative Material be stored to maintain its integrity?
The material must be stored according to the manufacturer’s guidelines to preserve its properties. While the exact conditions aren’t detailed here, dental composites generally require protection from extreme temperatures, moisture, and direct sunlight. Always refer to the packaging instructions for precise storage recommendations.
What regulatory pathways does the Prime-Dent Chemical Cure Composite Restorative Material follow, and how does this affect its use?
The material is cleared under FDA’s 510(k) pathway (traditional review, substantially equivalent determination) and complies with MDD and MDR regulations. This means it has undergone evaluation by the FDA’s Dental Advisory Committee (DE) and is classified under product code EBF for dental restorative materials, ensuring it meets established safety and performance standards for clinical use.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them.
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
MDR
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class II | Active |
| EUDAMED | European Union | MDR | — | Class II | Active |
| FDA 510(k) | United States | FDA_510K | K994224 | Class II | Active |
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Manufacturer
- Manufacturer
- Prime Dental Manufacturing, Inc.
Sources (2)
- FDA 510(k) K994224 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced May 19, 2026