Pulpdent Chemical Cure Pit and Fissure Sealant
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K945378 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 and Conditioner, classified under FDA regulation 872.3765. It is a resin-based material, such as polymethylmethacrylate, designed to seal depressions (pits and fissures) in the enamel of teeth, primarily in young children, to prevent dental caries (cavities). The sealant adheres to the tooth surface to create a protective barrier against bacterial penetration and acid erosion.
The Pulpdent Chemical Cure Pit and Fissure Sealant is supplied as a single-use dental material for in-office application by dental professionals. It is not MRI-safe or sterilized for reuse; each application requires a new unit. The device has received FDA 510K clearance under the Traditional pathway, classified as a Class II medical device. Storage conditions and specific lot details are not specified in the regulatory data but should follow manufacturer guidelines for dental resins.
Frequently asked questions
What is the primary purpose of the Pulpdent Chemical Cure Pit and Fissure Sealant, and who is it intended for?
The Pulpdent Chemical Cure Pit and Fissure Sealant is designed to seal the depressions (pits and fissures) in the enamel of teeth, primarily in young children, to prevent dental caries (cavities). It works by creating a protective barrier against bacterial penetration and acid erosion, reducing the risk of decay in vulnerable areas of the tooth.
Is this sealant reusable, or is it meant for single-use only?
The Pulpdent Chemical Cure Pit and Fissure Sealant is explicitly supplied as a single-use dental material. Each application requires a new unit, and it is not intended for reuse or sterilization.
How is this sealant applied, and what type of professional typically uses it?
This sealant is designed for in-office application by dental professionals. It is a resin-based material (polymethylmethacrylate) that adheres to the tooth surface to form a protective barrier, and it requires professional expertise to apply correctly.
What regulatory pathway was followed for FDA clearance of this device, and what class is it assigned?
The Pulpdent Chemical Cure Pit and Fissure Sealant received FDA clearance under the Traditional 510(k) pathway and is classified as a Class II medical device. This classification reflects its role as a dental device intended to prevent dental caries in specific tooth areas.
Are there any special storage instructions mentioned for this sealant?
The regulatory data does not specify storage conditions for this sealant. However, as with most dental resins, it is recommended to follow the manufacturer’s guidelines for optimal storage to maintain product integrity and effectiveness.
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: Pit & Fissure Sealant Archives - PULPDENT, Pulpdent Chemical Cure Pit and Fissure Sealant, Embrace™ WetBond™ Pit & Fissure Sealant - PULPDENT, PDF Pulpdent Corporation Revision Date: August 1, 2024 EN - Safety Data Sheet
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K945378 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K945378 24 fields · synced Sep 18, 2026