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IA-400 Prosthodontic Screwdriver Bredent 16934011

by W&H Dentalwerk Burmoos

Listed FDA GUDID listing, not in commercial distribution

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 NumberJ021169340111 UDI-DI Date12 Sep 2019ListedStatusListed GUDID: not 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  • Withdrawn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
IA-400 Prosthodontic Screwdriver Bredent
Generic Name
Surgical screwdriver, reusable
Model / Reference
16934011
Primary DI / UDI-DI
J021169340111
FDA Product Code
EKX
GMDN Term
Surgical screwdriver, reusable
Device Class
Class I
Regulation Number
872.4200
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Prescription Use
  • Serial Number
  • Manufacturing Date

Other properties (11)

  • 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
  • Lot / Batch Number: No
  • Expiration Date: No