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Enamelast

by Ultradent Products Inc. / Oratech, LLC

510(k) K132109

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

2 closed

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 NumberK132109 Date1 Nov 2013ClearedStatusActive

Recalls

2 recalls · FDA

    • Terminated Z-0690-2019 FDA Class II initiated 12 Jul 2018

    Dental varnish has the possibility of having an unpleasant and off flavor.

    • Terminated Z-0368-2019 FDA Class II initiated 6 Jul 2018

    Product has an unpleasant flavor due to a manufacturing process error resulting in an extraneous material being introduced into the product.

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  • Withdrawn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

Other devices from Ultradent Products Inc. / Oratech, LLC

  • Ultracem

    Class II