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Multiple Resin Tooth Bonding Agent

by Cosmedent, Inc.

510(k) K052501

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

1 closed

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 26 Oct 2026. What this means

Regulatory status

as of registry sync 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK052501 Date21 Oct 2005ClearedStatusActive

Recalls

1 recall · FDA

    • Terminated Z-0741-2018 FDA Class II initiated 28 Sep 2017

    Product packaged in a syringe that is not a lure lock syringe and the tip cold come off when expressing the material.

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  • Withdrawn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
KLE
Device Class
Class II
Regulation
21 CFR Part 872.3200
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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