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Ceramic Bracket Iceram Roth 0.018 - U3L(23) - 1UN 10.80.1123

by Orthometric - Industria E Comercio De Produtos Medicos E Odontologicos Ltda

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 Number07898488902489 UDI-DI Date16 Dec 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  • Withdrawn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
Ceramic Bracket Iceram Roth 0.018 - U3L(23) - 1UN
Generic Name
Orthodontic bracket, ceramic
Model / Reference
10.80.1123
Primary DI / UDI-DI
07898488902489
510(k) Number
FDA Product Code
NJM
GMDN Term
Orthodontic bracket, ceramic
Device Class
Class II
Regulation Number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Cleared under the same submission (K222847)

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