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Prima Plus 15762K

by Keystone Dental Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None ongoing

5 closed

Documents

510(k) K051614

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD76815762K0 UDI-DI Date8 May 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Abbreviated NumberK051614 Date9 Sep 2005DecidedStatusActive

Recalls

5 recalls · FDA

    • Terminated Z-2162-2018 FDA Class II initiated 1 May 2018 on shared 510(k) K051614

    The implants are mislabeled.

    • Terminated Z-0608-2018 FDA Class II initiated 20 Jun 2017 on shared 510(k) K051614

    Abutments are unable to accept the final abutment screw

    • Terminated Z-1818-2017 FDA Class II initiated 9 Mar 2017 on shared 510(k) K051614

    Straight PrimaConnex Implants contained Tapered PrimaConnex Implants

    • Terminated Z-0299-2017 FDA Class II initiated 15 Sep 2016 on shared 510(k) K051614

    Small diameter (SD) cover screw was packaged with the regular diameter implant and do not match the implant diameter (RD)

    • Terminated Z-0973-2013 FDA Class II initiated 11 Mar 2013 on shared 510(k) K051614

    Mislabeled: Cover screw that was in the package was a WD cover screw and not a SD cover screw as labeled

Recalls on a shared submission name another device cleared under the same FDA submission as this one.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Prima Plus
Generic name
Fixture/appliance dental drill bit, reusable
Model / reference
15762K
Primary DI / UDI-DI
D76815762K0
510(k) Number
FDA product code
DZA
GMDN term
Fixture/appliance dental drill bit, reusable
Device class
Class I
Regulation number
872.4130
GUDID distribution status
In Commercial Distribution

Related devices

Category: Fixture/appliance dental drill bit, reusable

Cleared under the same submission (K051614)

Show all (12)

Other devices from Keystone Dental Inc.

See all devices from Keystone Dental Inc. →

Properties

  • Lot / batch number

Other properties (14)

  • Supplied sterile: No
  • Sterilise before use: No
  • Single use: No
  • Implantable: No
  • Contains latex: No
  • Prescription use: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Premarket exempt: No
  • Serial number: No
  • Expiration date: No
  • Manufacturing date: No