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Diamante™ Mbt Ceramic Brackets (Kit) 57K-345-18

by G&H Wire Company, Inc.

Listed FDA GUDID listing, not in commercial distribution

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 Number10190886005835 UDI-DI Date24 Sep 2016ListedStatusListed GUDID: not 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  • Withdrawn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
Diamante™ Mbt Ceramic Brackets (Kit)
Generic Name
Orthodontic bracket, ceramic
Model / Reference
57K-345-18
Primary DI / UDI-DI
10190886005835
510(k) Number
FDA Product Code
NJM
GMDN Term
Orthodontic bracket, ceramic
Device Class
Class II
Regulation Number
872.5470
GUDID distribution status
Not in Commercial Distribution

Related devices

Cleared under the same submission (K132368)

Show all (12)

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Properties

  • Single Use
  • Prescription Use
  • Convenience Kit
  • Lot / Batch Number
  • Manufacturing Date

Other properties (9)

  • Sterile: No
  • Implantable: No
  • Contains Latex: No
  • Over-the-Counter: No
  • Combination Product: No
  • HCT/P: No
  • Premarket Exempt: No
  • Serial Number: No
  • Expiration Date: No