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Salvin Dental Specialties OFIBER-0.5CC

by Salvin Dental Specialties, LLC

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 Number00841336138766 UDI-DI Date28 Sep 2025ListedStatusListed 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  • Withdrawn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
Salvin Dental Specialties
Generic Name
Human-derived demineralized bone matrix implant
Model / Ref / Catalog
OFIBER-0.5CC
Primary DI / UDI-DI
00841336138766
510(k) Number
FDA Product Code
NUN
GMDN Term
Human-derived demineralized bone matrix implant
Device Class
Class II
Regulation Number
872.3930
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K103699)

Show all (12)

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Properties

  • Sterile
  • Single Use
  • Implantable
  • Prescription Use
  • HCT/P
  • Lot / Batch Number
  • Expiration Date
  • Manufacturing Date

Other properties (6)

  • Contains Latex: No
  • Over-the-Counter: No
  • Convenience Kit: No
  • Combination Product: No
  • Premarket Exempt: No
  • Serial Number: No