Activa Pit and Fissure Sealant with MCP
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K172169 FDA 510(k)
- FDA Product Code
- EBC FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3765 FDA 510(k)
- Regulation Number
- 872.3765 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
This device is a Pit and Fissure Sealant (as classified under FDA code EBC) designed to seal enamel depressions and fissures on the occlusal surfaces of teeth. It prevents bacterial penetration and reduces the risk of caries by creating a protective barrier over vulnerable areas of the tooth structure. The sealant incorporates mineral crystal technology (MCP) to enhance durability and bonding to the tooth surface, supporting long-term protection.
The Activa Pit and Fissure Sealant with MCP is supplied as a single-use dental product for professional application in clinical settings. It requires no sterilization as it is intended for one-time use per patient. The device is non-magnetic and MRI-safe, with no known contraindications for use in magnetic resonance environments. Packaging includes applicator tips and is stored at room temperature. The product holds an FDA 510(k) clearance under the Dental advisory committee, classified as a Class II device under regulation 872.3765.
Frequently asked questions
What is the primary purpose of the Pulpdent (Activa) Pit and Fissure Sealant with MCP, and how does the MCP technology improve its effectiveness?
The Pulpdent (Activa) Pit and Fissure Sealant with MCP is designed to seal enamel depressions and fissures on the occlusal surfaces of teeth, creating a protective barrier that prevents bacterial penetration and reduces the risk of caries. The MCP (mineral crystal) technology enhances durability and bonding to the tooth surface, supporting long-term protection by improving adhesion and resistance to wear.
Is the Pulpdent (Activa) Pit and Fissure Sealant with MCP intended for single-use or reusable applications, and what are the storage requirements?
The Pulpdent (Activa) Pit and Fissure Sealant with MCP is explicitly supplied as a single-use dental product for professional application in clinical settings. It does not require sterilization and is intended for one-time use per patient. The product is stored at room temperature, making it convenient for dental offices without special handling.
Can this sealant be safely used in patients who require MRI scans, and why?
Yes, the Pulpdent (Activa) Pit and Fissure Sealant with MCP is non-magnetic and MRI-safe, meaning it poses no known risks or contraindications for use in magnetic resonance environments. This makes it suitable for patients who may need MRI scans after application.
What regulatory pathway was followed for FDA clearance of this product, and what classification does it hold?
The Pulpdent (Activa) Pit and Fissure Sealant with MCP received FDA clearance through a 510(k) submission, classified as a Class II device under regulation 872.3765. The submission was reviewed by the Dental (DE) Advisory Committee and determined to be substantially equivalent to a predicate device, following a traditional clearance process.
How is the sealant supplied, and what components are included in the packaging?
The sealant is supplied as a professional-use dental product in single-use packaging, which includes applicator tips for easy application. The kit is designed for clinical settings and requires no additional sterilization, ensuring convenience and compliance with single-patient use protocols.
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. Sources consulted: Pulpdent (Activa) Pit and Fissure Sealant with MCP, Pulpdent (Activa) Pit and Fissure Sealant with MCP, Pit & Fissure Sealant Archives - PULPDENT, Pulpdent (Activa) Pit And Fissure Sealant With MCP
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K172169 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
Sources (1)
- FDA 510(k) K172169 24 fields · synced Sep 20, 2026