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Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut M1.4 SFA10PKDK-OA1.4

by Smart Denture Conversions, LLC

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 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD990SFA10PKDKOA140 UDI-DI Date17 Jun 2026ListedStatusListed 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  • Withdrawn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
Separable Fastener Assembly 10PK - Drill Kit Included, Omnibut M1.4
Generic Name
Dental implant suprastructure, temporary, preformed, single-use
Model / Reference
SFA10PKDK-OA1.4
Primary DI / UDI-DI
D990SFA10PKDKOA140
FDA Product Code
NHA, EJX, NDP
GMDN Term
Dental implant suprastructure, temporary, preformed, single-use
Device Class
Class II
Regulation Number
872.3630, 872.3130, 872.3980
GUDID distribution status
In Commercial Distribution
Sterilization Method
Moist Heat or Steam Sterilization
MRI Safety
MR Conditional

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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