Prime-Dent Chemical Cure Pit & Fissure Sealant
FDA 510(k)EUDAMEDClass II (US FDA 510(k))
Identifiers
- 510(k) Number
- K012794 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 Pit & Fissure Sealant is a dental material classified as a Pit and Fissure Sealant (Product Code EBF) under the Dental advisory committee. It is designed to prevent dental caries by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars, reducing bacterial penetration and plaque accumulation in these high-risk areas.
This sealant is supplied as a single-use, chemical-cure system and is intended for use in dental offices by trained professionals. It is not sterile at the point of sale but is packaged in a manner that ensures sterility upon opening for clinical use. The device is regulated under FDA 510K clearance, MDD, and MDR compliance, with no third-party certification required. Storage should follow manufacturer instructions to maintain product integrity.
Frequently asked questions
What is the Prime-Dent Chemical Cure Pit & Fissure Sealant used for in dental practice?
The Prime-Dent Chemical Cure Pit & Fissure Sealant is specifically designed to prevent dental caries (cavities) by sealing the deep grooves and fissures on the chewing surfaces of molars and premolars. It works by reducing bacterial penetration and plaque accumulation in these high-risk areas, helping to protect teeth from decay.
Is the Prime-Dent Chemical Cure Pit & Fissure Sealant single-use or reusable?
The Prime-Dent Chemical Cure Pit & Fissure Sealant is supplied as a single-use chemical-cure system. This means each package is intended for one application only, ensuring optimal performance and sterility for the patient.
How is the sterility of the Prime-Dent Chemical Cure Pit & Fissure Sealant maintained?
The sealant is not sterile at the point of sale, but it is packaged in a way that ensures sterility upon opening for clinical use. Proper storage following manufacturer instructions is required to maintain product integrity and prevent contamination.
What types of regulatory compliance does the Prime-Dent Chemical Cure Pit & Fissure Sealant meet?
The sealant is regulated under FDA 510K clearance, MDD (Medical Device Directive), and MDR (Medical Device Regulation) compliance. It does not require third-party certification, and its classification falls under the Dental advisory committee (DE) with a Product Code EBF for Pit and Fissure Sealants.
How should the Prime-Dent Chemical Cure Pit & Fissure Sealant be stored to ensure it remains effective?
Storage instructions must be followed as provided by the manufacturer to preserve the product’s integrity. While specific conditions aren’t detailed here, typical chemical-cure dental materials require protection from moisture, extreme temperatures, and direct light to maintain stability and performance.
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 | K012794 | Class II | Active |
Is this your device? Claim it to add documentation and request validation.
Manufacturer
- Manufacturer
- Prime Dental Manufacturing, Inc.
Sources (2)
- FDA 510(k) K012794 24 fields · synced Sep 18, 2026
- EUDAMED 1 fields · synced Jun 3, 2026