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New Europa I - Flexy Niti S.E. Round Ovoid Wire 0.014 Upper -10UN 51.26.2014

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

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 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number07908611216021 UDI-DI Date26 May 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  • Withdrawn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
New Europa I - Flexy Niti S.E. Round Ovoid Wire 0.014 Upper -10UN
Generic Name
Orthodontic archwire
Model / Reference
51.26.2014
Primary DI / UDI-DI
07908611216021
FDA Product Code
DZC
GMDN Term
Orthodontic archwire
Device Class
Class I
Regulation Number
872.5410
GUDID distribution status
In Commercial Distribution

Other devices from Orthometric – Indústria e Comércio de Produtos Médicos e Odontológicos Ltda

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Properties

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

Other properties (8)

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