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InterActive® Healing Collar Narrow 6534-13N

by Implant Direct Sybron Manufacturing LLC

Listed FDA GUDID listing, no authorization on record

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 Number10841307109938 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

4 recalls · FDA

    • Terminated Z-0363-2020 FDA Class II initiated 26 Oct 2018 on shared 510(k) K130572

    packaging error; An internal QA inspection revealed that a incorrect healing collar could have been packaged in an implant assembly kit.

    • Terminated Z-1917-2018 FDA Class II initiated 14 Mar 2018 on shared 510(k) K130572

    The cap on the vial might be labeled with the incorrect part number but the main vial label is correct.

    • Terminated Z-0539-2018 FDA Class II initiated 23 Jan 2018

    InterActive Healing Collar, Lot Number 104203, labeled as sterile with distributed prior to being sterilized.

    • Terminated Z-2551-2018 FDA Class II initiated 3 Mar 2017 on shared 510(k) K130572

    The main vial label lists the incorrect part number, but the cap label is correct.

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  • Withdrawn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
InterActive® Healing Collar Narrow
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
6534-13N
Primary DI / UDI-DI
10841307109938
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
In Commercial Distribution

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K130572)

Show all (12)

Other devices from Implant Direct Sybron Manufacturing LLC

See all devices from Implant Direct Sybron Manufacturing LLC →

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