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Amorphous Diamond Coated Drill

by Nobel Biocare Uas, Inc.

510(k) K990846

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

15 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 NumberK990846 Date10 Jun 1999ClearedStatusActive

Recalls

15 recalls · FDA

  • 14 recalls, same reason

    • Terminated Z-1314-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1304-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1305-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1309-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1323-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1311-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1307-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1308-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1306-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1310-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1315-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1303-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1313-2020 FDA Class II initiated 14 Mar 2019
    • Terminated Z-1312-2020 FDA Class II initiated 14 Mar 2019

    Due to a problem in the packaging sealing process at the supplier of the affected devices, it cannot be guaranteed that the sterilized medical devices in the scope of this recall remain sterile during their shelf-life.

    • Terminated Z-2375-2016 FDA Class II initiated 20 Jul 2016

    Incorrect drill protocol in the Instructions for Use (IFU)

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  • Withdrawn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
DZI
Device Class
Class II
Regulation
21 CFR Part 872.4120
Advisory Committee
Dental
FDA Decision
SESE Substantially Equivalent

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