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Nobelreplace Tapered Conical Connection

by Nobel Biocare USA, LLC

510(k) K062566

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

27 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 NumberK062566 Date6 Dec 2006ClearedStatusActive

Recalls

27 recalls · FDA

  • 26 recalls, same reason

    • Terminated Z-1432-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1419-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1438-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1437-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1416-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1440-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1415-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1426-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1421-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1427-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1417-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1439-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1429-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1425-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1436-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1424-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1428-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1430-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1435-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1422-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1418-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1414-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1420-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1423-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1434-2015 FDA Class II initiated 9 Mar 2015
    • Terminated Z-1433-2015 FDA Class II initiated 9 Mar 2015

    A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads.

    • Terminated Z-1431-2015 FDA Class II initiated 9 Mar 2015

    A material used in the packaging of the dental implants may impart a sticky substance on the top surfaces of the implants and in some cases on the first threads..

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
DZE
Device Class
Class II
Regulation
21 CFR Part 872.3640
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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