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Pulpdent Cavity Varnish

FDA 510(k)

Class II (US FDA 510(k))

510(k) K974398

by Pulpdent Corporation

Identifiers

510(k) Number
K974398 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 Varnish is a dental varnish classified as a cavity varnish, designed to protect and seal dentinal tubules. According to the FDA’s classification, it functions as a desensitizing agent and dentinal tubule sealer, forming a protective barrier on exposed dentin or cementum to reduce sensitivity and prevent acid diffusion.

This single-use dental varnish is applied to exposed dentin or cementum following procedures such as scaling, prophylaxis, or cavity preparation, prior to cementation or pin/post seating. Supplied in sterile form, it adheres to the tooth surface to create a hard, protective coating. Authorized under FDA 510(k) clearance (K974398), it complies with dental regulations (872.3260) and is intended for use in clinical dental settings.

Frequently asked questions

What is the primary purpose of the Pulpdent Cavity Varnish in dental procedures?

The Pulpdent Cavity Varnish is designed to protect and seal dentinal tubules, acting as a desensitizing agent and dentinal tubule sealer. It creates a hard, protective barrier on exposed dentin or cementum to reduce sensitivity and prevent acid diffusion, making it ideal for use after procedures like scaling, prophylaxis, or cavity preparation—before cementation or pin/post seating.

Is the Pulpdent Cavity Varnish intended for single-use or can it be reused?

The Pulpdent Cavity Varnish is explicitly labeled as a single-use product. Each application requires a new unit to ensure sterility and effectiveness, as reuse could compromise its protective properties and regulatory compliance.

How is the Pulpdent Cavity Varnish supplied, and is it sterile?

The Pulpdent Cavity Varnish is supplied in a sterile form, ready for immediate clinical use. This ensures safety and reliability when applied to exposed dentin or cementum during dental procedures.

What regulatory pathway was followed for FDA clearance of the Pulpdent Cavity Varnish?

The Pulpdent Cavity Varnish received FDA clearance through a 510(k) submission (K974398) under the Traditional clearance type, classified as Substantially Equivalent to a predicate device. The submission was reviewed by the Dental (DE) Advisory Committee and filed under product code LBH, complying with dental regulations (872.3260).

How should the Pulpdent Cavity Varnish be stored, and are there any special handling requirements?

While the data does not specify storage conditions explicitly, the product is supplied sterile, so it should be stored in a clean, dry environment away from direct sunlight or extreme temperatures to maintain its integrity. Always follow manufacturer guidelines for unopened packaging to preserve sterility until use.

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 ® Corporation - Advancing Dentistry Together, PULPDENT CAVITY VARNISH (K974398) — FDA 510(k) | Innolitics, Pulpdent Restorative Materials & Varnish, Amazon.com: Pulpdent Corp Pulpdent FVT Embrace Varnish 5% Sodium ...

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation
FDA Applicant
Pulpdent Corp.

Sources (1)

  • FDA 510(k) K974398 24 fields · synced Sep 20, 2026