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Swish™ Healing Collar Narrow 9048-15NH

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

11 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 Number10841307127246 UDI-DI Date12 Apr 2021ListedStatusListed GUDID: in commercial distribution

Recalls

11 recalls · FDA

    • Terminated Z-1157-2020 FDA Class II initiated 11 Oct 2019 on shared 510(k) K090234

    Through a customer complaint and and internal investigation it was determined that some implant packages contain the incorrect cover screw and extender. This could result in delay in surgery and/or a potential new surgical procedures to place the correct parts. The level of severity varies based on a one or two stage surgery.

    • Terminated Z-1041-2020 FDA Class II initiated 7 Oct 2019 on shared 510(k) K090234

    Some dental implant packages contain incorrect implants, which could lead to surgery rescheduling.

    • Terminated Z-0364-2020 FDA Class II initiated 9 Aug 2019 on shared 510(k) K090234

    A QA inspection confirmed that a Healing Collar (Part number 8735-15) was packaged instead of the Implant ordered.

    • Terminated Z-0018-2020 FDA Class II initiated 8 Aug 2018 on shared 510(k) K090234

    Two units in distribution were found to be mislabeled on the vial cap with the incorrect part number.

    • Terminated Z-1167-2018 FDA Class II initiated 19 Jan 2018 on shared 510(k) K090234

    The extender that is packaged with the SwishTapered" and SwishPlus" Implant may have been packaged in the incorrect position (upside down in the plastic retainer).

    • Terminated Z-0185-2018 FDA Class II initiated 10 Oct 2017 on shared 510(k) K090234

    One reported complaint and discovered that the outer vial was out of round and undersized. Therefore a portion of the opening may not allow inner vial and components to slide freely out of the vial. As a result, the cap could possibly not be screwed on properly and the sterilization compromised.

    • Terminated Z-0007-2018 FDA Class II initiated 21 Jul 2017

    The Swish Duo-Grip Healing Collar part number 9048-13H (4.8mm) package contained a 9037-13H (3.7 mm) component.

    • Terminated Z-1112-2017 FDA Class II initiated 12 Dec 2016 on shared 510(k) K090234

    The extender product code (9037-03) that is packaged with the SwishTapered (Part Number 933308; Lot Number 73241) Implant was packaged in the incorrect position. This discrepancy may lead to the possibility of extender not seating properly on the implant, which may lead to micro-leakage and a possible infection to the patient.

    • Terminated Z-0961-2017 FDA Class II initiated 28 Nov 2016 on shared 510(k) K090234

    Consignees received product 6060-62, Replant Overdenture Abutment with the label for 4500-61 GoDirect Screw-Retaining Top.

    • Terminated Z-1920-2018 FDA Class II initiated 15 Nov 2016 on shared 510(k) K090234

    The vial cap was mislabeled with the incorrect part number of 855708 but the product description on the cap was correct. The main vial label was correctly labeled.

    • Terminated Z-1267-2016 FDA Class II initiated 4 Mar 2016 on shared 510(k) K090234

    Implant Direct Sybron Manufacturing, LLC is recalling GoDirect Implants because some consignees did not receive the correct tool to drive the implant to bone level.

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
Swish™ Healing Collar Narrow
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
9048-15NH
Primary DI / UDI-DI
10841307127246
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 (K090234)

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