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BONEFIT IMPLANT SYSTEM ACCESSORIES & INSTRUMENTS Final Copings

by Institut Straumann SA 4 variants

Listed FDA GUDID listing, no authorization on record

Valid until

Not applicable

Database listing, no authorization

FDA recalls

None found

in data synced 23 Oct 2026

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 Number07630031724816 UDI-DI Date24 Sep 2015ListedStatusListed GUDID: in commercial distribution

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Specification

GUDID

Trade Name
Bonefit Implant System Accessories & Instruments
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Ref / Catalog
Final Copings, 048.505
Primary DI / UDI-DI
07630031724816
510(k) Number
FDA Product Code
DZE
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class II
Regulation Number
872.3640
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization

Related devices

Category: Dental implant suprastructure, permanent, preformed

Cleared under the same submission (K894844)

Show all (12)

Other devices from Institut Straumann SA

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Properties

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

Other properties (10)

  • Sterile: No
  • Contains Latex: 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