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ScrewPlant® Healing Collar Narrow 1037-12N

by Implant Direct Sybron Manufacturing LLC

Listed FDA GUDID listing, not in commercial distribution

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None ongoing

4 closed

Documents

None

No authorization documents

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 Number10841307114796 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: not in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-0010-2020 FDA Class II initiated 7 Aug 2018 on shared 510(k) K061319

    The incorrect device was packaged in the vial.

    • Terminated Z-2376-2018 FDA Class II initiated 18 May 2018 on shared 510(k) K061319

    Due to out of specification, the clinician would not be able to fit and engage the abutment with the implant

    • Terminated Z-2125-2017 FDA Class II initiated 2 May 2017 on shared 510(k) K061319

    Implant Direct Sybron Manufacturing is recalling the Legacy Full-Contour Abutment 3.5mmD Assembly because it may be out of Implant Direct specification.

    • Terminated Z-2320-2016 FDA Class II initiated 5 Jul 2016 on shared 510(k) K061319

    Issue with design specification; oversized condition.

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  • Withdrawn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 — GUDID listing Listed

Specification

GUDID

Trade Name
ScrewPlant® Healing Collar Narrow
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
1037-12N
Primary DI / UDI-DI
10841307114796
510(k) Number
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class II
Regulation Number
872.3630
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K061319)

Show all (12)

Other devices from Implant Direct Sybron Manufacturing LLC

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (8)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Manufacturing Date: No