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GenTek® Ti Prosthetic Base Coping, Low Profile, 4.8mmD ZFX11-ZB-LP-48-US

by Zfx GmbH

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

Not checked

No FDA submission to match recalls against

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 Number04251881715002 UDI-DI Date26 Mar 2024ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — GUDID listing Listed

Specification

GUDID

Trade Name
GenTek® Ti Prosthetic Base Coping, Low Profile, 4.8mmD
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Reference
ZFX11-ZB-LP-48-US
Primary DI / UDI-DI
04251881715002
FDA Product Code
NDP
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class I
Regulation Number
872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

Related devices

Category: Dental implant suprastructure, permanent, preformed

Other devices from Zfx GmbH

See all devices from Zfx GmbH →

Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Premarket Exempt
  • Lot / Batch Number

Other properties (9)

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