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Varnishamerica

by Medical Products Laboratories, Inc.

510(k) K040098

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK040098 Date4 Feb 2004ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

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

Overview

AI-generated summary, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

Varnishamerica is a cavity varnish, which is a device consisting of a compound intended to coat a prepared cavity of a tooth before the insertion of restorative materials. It is designed to prevent the penetration of restorative materials, such as amalgam, into the dentinal tissue.

This device is classified as a Class II medical device under regulation number 872.3260. It is manufactured by Medical Products Laboratories, Inc. and has received FDA 510(k) authorization.

Other devices from Medical Products Laboratories, Inc.

Questions

AI-generated answers, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the primary purpose of Varnishamerica?

    Varnishamerica is a cavity varnish intended to coat a prepared tooth cavity before the insertion of restorative materials. Its function is to prevent the penetration of materials, such as amalgam, into the dentinal tissue.

  • How is this device classified for regulatory purposes?

    Varnishamerica is classified as a Class II medical device under regulation number 872.3260. It has received FDA 510(k) authorization under the K040098 submission.

  • Who is the manufacturer of this cavity varnish?

    Varnishamerica is manufactured by Medical Products Laboratories, Inc., located in Philadelphia, Pennsylvania.