Pulpdent Cavity Preparation III
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994180 FDA 510(k)
- FDA Product Code
- LBH FDA 510(k)
Classification
- Device Class
- Class II FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.3260 FDA 510(k)
- Regulation Number
- 872.3260 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The Pulpdent Cavity Preparation III is a Cavity Varnish, a dental adhesive solution designed to protect dentin and pulp tissue during tooth preparation. It forms a protective barrier to reduce microleakage and sensitivity, supporting the longevity of restorative materials such as veneers, inlays, crowns, onlays, amalgam, and composite fillings.
This liquid solution is intended for use in clinical dental settings by professionals. Supplied as a single-use application, it contains glutaraldehyde, water, and sodium fluoride. The device is classified as Class II under FDA regulations (872.3260) and holds a 510(k) clearance (K994180) for substantial equivalence in dental applications. Storage and handling follow standard aseptic protocols for liquid dental adhesives.
Frequently asked questions
What is the primary purpose of the Pulpdent Cavity Preparation III in dental procedures?
The Pulpdent Cavity Preparation III is a cavity varnish designed to create a protective barrier over dentin and pulp tissue during tooth preparation. Its main function is to reduce microleakage and sensitivity, thereby supporting the longevity of restorative materials such as veneers, inlays, crowns, onlays, amalgam, and composite fillings.
Is the Pulpdent Cavity Preparation III intended for single-use or can it be reused?
The Pulpdent Cavity Preparation III is explicitly supplied as a single-use application. This ensures sterility and consistency in clinical settings, as reuse could compromise its effectiveness or introduce contamination risks.
What are the key ingredients in the Pulpdent Cavity Preparation III, and how might they benefit dental procedures?
The Pulpdent Cavity Preparation III contains glutaraldehyde, water, and sodium fluoride. Glutaraldehyde acts as a preservative and helps form a protective film, while sodium fluoride contributes to remineralization and strengthens tooth structure, reducing sensitivity and promoting long-term restorative success.
How should the Pulpdent Cavity Preparation III be stored, and what precautions should be taken?
The Pulpdent Cavity Preparation III follows standard aseptic protocols for liquid dental adhesives during storage and handling. Since it is a single-use liquid solution, it should be stored in a clean, dry place away from direct sunlight or extreme temperatures to maintain its integrity and effectiveness until use.
What regulatory pathway was followed for the FDA clearance of the Pulpdent Cavity Preparation III?
The Pulpdent Cavity Preparation III received FDA clearance through a 510(k) submission, specifically under the traditional review pathway. It was determined to be substantially equivalent to a predicate device in dental applications, classified under FDA code 872.3260 for cavity varnishes, and holds clearance number K994180.
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 CAVITY PREPARATION III (K994180) — FDA 510 (k) | Innolitics, PDF K994180 - Pulpdent Cavity Preparation Iii, Pulpdent Cavity Preparation Iii - Beudamed, PULPDENT ® Corporation - Advancing Dentistry Together, Product Catalog - Pulpdent Corporation - PDF Catalogs | Technical ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994180 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K994180 24 fields · synced Sep 18, 2026