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Cortical Bone Drill for 3.7mmD Implant CBD3.7

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 Number10841307116998 UDI-DI Date23 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

3 recalls · FDA

    • Terminated Z-1126-2020 FDA Class II initiated 9 Jan 2019 on shared 510(k) K081396

    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 on shared 510(k) K081396

    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 on shared 510(k) K081396

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

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  • Withdrawn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
Cortical Bone Drill for 3.7mmD Implant
Generic Name
Fluted surgical drill bit, reusable
Model / Ref / Catalog
CBD3.7
Primary DI / UDI-DI
10841307116998
510(k) Number
FDA Product Code
DZI
GMDN Term
Fluted surgical drill bit, reusable
Device Class
Class II
Regulation Number
872.4120
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Fluted surgical drill bit, reusable

Cleared under the same submission (K081396)

Show all (12)

Other devices from Implant Direct Sybron Manufacturing LLC

See all devices from Implant Direct Sybron Manufacturing LLC →

Properties

  • Prescription Use
  • Lot / Batch Number

Other properties (12)

  • Sterile: No
  • Single Use: No
  • Implantable: No
  • Contains Latex: 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