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Dental Varnish

by Adp Intl., Inc. 510(k)

Active United States

510(k) K760982

Overview

Dental Varnish is a cavity varnish device used in dentistry. It is a dental material applied to the walls and floor of a prepared tooth cavity to seal dentinal tubules, reduce postoperative sensitivity, and protect pulp tissue.

The device is supplied by Adp Intl., Inc. and has FDA 510(k) clearance under K760982. It is classified as a Class II device under regulation number 872.3260, with product code LBH, and was determined to be substantially equivalent. The device is intended for dental use and is regulated under the FDA's dental specialty classification.

AI-generated from registry data, 1 Oct 2026.Not verified by deviCERTS or the manufacturer

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK760982 Date15 Nov 1976ClearedStatusActive

Coverage

1 jurisdiction

United States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of AmericaUnited States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

510(k)

510(k) Number
FDA Product Code
LBH
Device Class
Class II
Regulation
21 CFR Part 872.3260
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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Questions

  • What is Dental Varnish used for?

    Dental Varnish is used in dentistry as a cavity varnish device applied to the walls and floor of a prepared tooth cavity. It seals dentinal tubules, reduces postoperative sensitivity, and protects pulp tissue during dental procedures.

  • How is Dental Varnish supplied and by whom?

    Dental Varnish is supplied by Adp Intl., Inc. The device is provided as a dental material for professional use in dental settings, intended for application to prepared tooth cavities.

  • Is Dental Varnish sterile or single-use?

    The device data does not specify whether Dental Varnish is sterile or single-use. As a cavity varnish material applied directly to tooth surfaces, it is typically used as a single-use applicator per treatment, but sterility status is not indicated in the provided information.

  • What regulatory clearance does Dental Varnish have?

    Dental Varnish has FDA 510(k) clearance under submission number K760982. It was determined to be substantially equivalent and is classified as a Class II device under regulation 872.3260 with product code LBH.