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Swish™ Healing Collar 9048-15

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

3 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 Number10841307116172 UDI-DI Date14 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-1126-2020 FDA Class II initiated 9 Jan 2019

    Due to a complaint received and internal investigation it was determined that implant vials were distributed with incorrect color coded vials and caps. The part/lot numbers were correct, the customer received the product they ordered, however the color on the vial label and cap labels were incorrect.Specifically, the color coded vial and cap does not match the implant size described on the vial. As a result of the incorrect color on the vial and cap, the surgeon may not be certain if the implant received was the correct size. This could result in a delay in surgery, risk of infection if the surgical site has to be closed up and a second round of anesthesia.

    • Terminated Z-1168-2018 FDA Class II initiated 19 Jan 2018

    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-0396-2016 FDA Class II initiated 28 Oct 2015

    Implant Direct Sybron Manufacturing, LLC is recalling 26 lots of DGDE DirectGuide Drill Extender because of a possible dropping of the drill.

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  • Withdrawn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
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
9048-15
Primary DI / UDI-DI
10841307116172
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 (K081396)

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