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Omnibut, Internal Hex 5.7, M1.4 23IH57-OA1.4

by Smart Denture Conversions, LLC GUDID

Listed FDA GUDID listing, no authorization on record

Regulatory status

as of 28 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing NumberD99023IH57OA140 UDI-DIDate17 Jun 2026ListedStatusListed GUDID: in commercial distribution

Coverage

1 jurisdiction

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  • Withdrawn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

United States — GUDID listing Listed

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

Specification

GUDID

Trade Name
Omnibut, Internal Hex 5.7, M1.4
Generic Name
Dental implant suprastructure, permanent, preformed
Model / Reference
23IH57-OA1.4
Primary DI / UDI-DI
D99023IH57OA140
FDA Product Code
NHA
GMDN Term
Dental implant suprastructure, permanent, preformed
Device Class
Class II
Regulation Number
872.3630
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