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EXTERNA® UNIVERSAL PLATFORM HEALING ABUTMENT Ø4 L:4 mm PCU44

by Biotechnology Institute Sl

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 Number08435389800835 UDI-DI Date17 Oct 2015ListedStatusListed 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  • Withdrawn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
EXTERNA® UNIVERSAL PLATFORM HEALING ABUTMENT Ø4 L:4 mm
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
PCU44
Primary DI / UDI-DI
08435389800835
FDA Product Code
DZE
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
Size
Outer Diameter — 4 Millimeter
Length — 4 Millimeter

Related devices

Category: Dental implant suprastructure, temporary, preformed, single-use

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Properties

  • Single Use
  • Implantable
  • Prescription Use
  • Lot / Batch Number
  • Expiration Date

Other properties (9)

  • Sterile: No
  • 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