Skip to content

EXTERNA® WIDE PLATFORM HEALING ABUTMENT Ø6.5 L:4 mm PCA64

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 Number08435389801276 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  • Withdrawn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® WIDE PLATFORM HEALING ABUTMENT Ø6.5 L:4 mm
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
PCA64
Primary DI / UDI-DI
08435389801276
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
Length — 4 Millimeter
Outer Diameter — 6.5 Millimeter

Related devices

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

Other devices from Biotechnology Institute Sl

See all devices from Biotechnology Institute Sl →

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