Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 With Fluoride
FDA 510(k)Class II (US FDA 510(k))
Identifiers
- 510(k) Number
- K994182 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 1 and Pulpdent Cavity Preparation 1 With Fluoride are dental cavity varnishes designed to protect dental pulp during tooth preparation. These products are intended for application in cavities prior to restorative procedures such as veneers, inlays, crowns, onlays, amalgam, or composite restorations, providing a protective barrier to the pulp tissue.
These products are supplied as single-use solutions for professional dental use. The Pulpdent Cavity Preparation 1 contains disodium EDTA and benzalkonium chloride, while the fluoride variant includes additional fluoride. Both are classified as Class II devices under FDA regulations and have received 510(k) clearance as substantially equivalent to a predicate device. They are non-sterile and intended for use in dental offices.
Frequently asked questions
What is the primary purpose of the Pulpdent Cavity Preparation 1 and its fluoride variant during dental procedures?
These products are designed to act as a protective barrier for dental pulp tissue during tooth preparation. They are applied to the cavity before restorative procedures like veneers, inlays, crowns, onlays, amalgam, or composite restorations to shield the pulp from potential irritation or damage during the preparation process.
Are the Pulpdent Cavity Preparation 1 products single-use or reusable, and how should they be stored?
Both the Pulpdent Cavity Preparation 1 and its fluoride variant are supplied as single-use solutions intended exclusively for professional dental use. Since they are non-sterile, they should be stored in a clean, dry place away from direct sunlight and extreme temperatures, following the manufacturer’s guidelines to maintain product integrity until use.
What key ingredients differentiate the fluoride variant from the standard Pulpdent Cavity Preparation 1?
The standard Pulpdent Cavity Preparation 1 contains disodium EDTA and benzalkonium chloride, while the fluoride variant includes these same ingredients plus additional fluoride. The fluoride variant is intended for use when extra protection and remineralization benefits are desired for the tooth structure.
How is the regulatory status of these products determined, and what does that mean for dental professionals?
The Pulpdent Cavity Preparation 1 and its fluoride variant are classified as Class II medical devices under FDA regulations and have received 510(k) clearance, meaning they are deemed substantially equivalent to a predicate device already on the market. This clearance confirms their safety and effectiveness for the intended use as cavity varnishes in dental offices, ensuring dental professionals can rely on their performance and compliance with regulatory standards.
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 1, Pulpdent Cavity Preparation 1 With ..., Pulpdent Cavity Preparation 1, Pulpdent Cavity Preparation 1 With ..., Bases & Liners - PULPDENT, PULPDENT - US Dental Depot, Pulpdent Corporation - Shop Discount Dental Deals By Brand | Dental ...
Authorization Coverage (1 country)
Regulatory Authorizations
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| FDA 510(k) | United States | FDA_510K | K994182 | Class II | Active |
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Manufacturer
- Manufacturer
- Pulpdent Corporation
- FDA Applicant
- Pulpdent Corp.
Sources (1)
- FDA 510(k) K994182 24 fields · synced Sep 20, 2026