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Colla-Tec Absorbable Collagen Membrane

by Colla-Tec, Inc.

510(k) K924408

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 NumberK924408 Date22 Aug 1995ClearedStatusActive

Recalls

2 recalls · FDA

  • 2 recalls, same reason

    • Terminated Z-1301-2013 FDA Class II initiated 28 Mar 2013
    • Terminated Z-1298-2013 FDA Class II initiated 28 Mar 2013

    Due to the process deviation, product lots in question may have been released with higher levels of pyrogens than permitted by the specifications for the products.

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  • Withdrawn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
LYC
Device Class
Class II
Regulation
21 CFR Part 872.3930
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent