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Bioform® IPN Anteriors B54 U 45H

by Dentsply International

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD00116636UB5445H0 UDI-DI Date10 Oct 2016ListedStatusListed 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  • Withdrawn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
Bioform® IPN Anteriors
Generic Name
Resin artificial teeth
Model / Ref / Catalog
B54 U 45H, 16636
Primary DI / UDI-DI
D00116636UB5445H0
FDA Product Code
ELM
GMDN Term
Resin artificial teeth
Device Class
Class II
Regulation Number
872.3590
GUDID distribution status
Not in Commercial Distribution

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Properties

  • Single Use
  • Lot / Batch Number

Other properties (12)

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