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Copal Varnish with Fluoride

FDA 510(k)

Class II (US FDA 510(k))

510(k) K100503

by Pulpdent Corporation

Identifiers

510(k) Number
K100503 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)

Copal Varnish with Fluoride is a resin-based dental varnish designed to treat dental hypersensitivity. It functions by forming an adherent film that occludes dentinal tubules on enamel or dentin, providing professional-level protection against sensitivity.

This product is supplied as a single-use application in dental settings and has received FDA 510(k) clearance under product code LBH, classified as a Class II device under Special Controls. It is not described as sterile or reusable, and no MRI safety information is provided. The varnish is distributed in standard dental packaging for professional use.

Frequently asked questions

What is the primary purpose of Pulpdent Copal Varnish with Fluoride in dental treatments?

Pulpdent Copal Varnish with Fluoride is designed specifically to treat dental hypersensitivity by forming an adherent film that occludes dentinal tubules on enamel or dentin. This protective layer helps reduce sensitivity to stimuli like temperature or pressure, providing professional-level relief for patients.

Is this product intended for single-use or can it be reused in a clinical setting?

The product is explicitly supplied as a single-use application for dental settings. It is not labeled as reusable, so each package should be used once and then discarded to maintain efficacy and hygiene standards.

How is Pulpdent Copal Varnish with Fluoride packaged and distributed for professional use?

The varnish is distributed in standard dental packaging tailored for professional use in clinical environments. This ensures ease of handling and application while maintaining the product’s integrity for single-use scenarios.

Does this product require any special storage conditions, and is it sterile?

The provided data does not specify any special storage conditions, but it is important to follow general dental product storage guidelines to preserve its effectiveness. Additionally, the product is not described as sterile, so standard non-sterile handling protocols should apply.

What regulatory pathway was followed for FDA clearance of this dental varnish?

Pulpdent Copal Varnish with Fluoride received FDA clearance through a 510(k) submission, classified under product code LBH as a Class II device with Special Controls. The submission was reviewed by the Dental Expert Panel (DE) and determined to be substantially equivalent to a predicate device, following a traditional clearance process.

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 COPAL VARNISH WITH FLUORIDE - Innolitics, PDF PULPDENT CORPORATION J , - - (D'tzC-L5 - Food and Drug Administration, K100503 - PULPDENT COPAL VARNISH WITH FLUORIDE | FDA 510 (k), PULPDENT COPAL VARNISH WITH FLUORIDE 510(k) K100503 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Pulpdent Corporation

Sources (1)

  • FDA 510(k) K100503 24 fields · synced Sep 18, 2026