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G&H Orthodontics® 125-U2-2R-V

by G&H Wire Company, Inc.

Ref 131-U2-2L-V

Active European Union and United States. Also listed in GUDID (US).

CE MDR 510(k)

Valid until

No date given

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 23 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K132368

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
European UnionCE/MDR EUDAMED Number0190886CeramicBrackets7H Basic UDI-DI 10190886271681UDI-DIDate16 Sep 2022RegisteredStatusActive
United StatesGUDID listing GUDID Number10190886271681 UDI-DI Date11 Dec 2019ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE GUDID from GUDID Substantially Equivalent · Traditional NumberK132368 Date19 Dec 2013DecidedStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · GUDID

Trade name
G&H Orthodontics ® EUDAMEDGUDID
G&H Orthodontics® GUDID
Generic name
Orthodontic bracket, ceramic
Orthodontic bracket, metal
Device name
Orthodontic Ceramic Brackets
Model / reference
131-U2-2L-V, 125-U2-2R-V
Primary DI / UDI-DI
10190886271681, 10190886015162
Basic UDI-DI
0190886CeramicBrackets7H
Unit of use DI
00190886271684
510(k) Number
FDA product code
NJM, EJF
EMDN code
Q010403 Orthodontic brackets and buttons
GMDN term
Orthodontic bracket, ceramic
Orthodontic bracket, metal
Device class
Class IIa EUDAMED
Class II GUDID
Class I GUDID
Regulation number
872.5470, 872.5410
EU registration type
Standard device
EU market of registration
Netherlands
GUDID distribution status
In Commercial Distribution

Truth per registry

2 sources · 1 field differs

FieldEUDAMEDGUDID
Device classEUDAMED
Class IIa
GUDID
Class II
Class I

Related devices

Category: Orthodontic bracket, ceramic

Cleared under the same submission (K132368)

Show all (12)

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Properties

  • Single use
  • Prescription use
  • Premarket exempt NoGUDIDYesGUDID
  • Lot / batch number
  • Manufacturing date

Other properties (20)

  • Supplied sterile: No
  • Sterilise before use: No
  • Implantable: No
  • Reusable: No
  • Contains latex: No
  • Reprocessed single-use device: No
  • Contains CMR substances (carcinogenic, mutagenic or toxic to reproduction): No
  • Incorporates a substance derived from human blood or plasma: No
  • Contains human tissues or cells: No
  • Contains animal tissues or cells: No
  • Contains endocrine-disrupting substances: No
  • Administering medicine: No
  • Measuring function: No
  • Incorporates a medicinal substance: No
  • Over-the-counter: No
  • Convenience kit: No
  • Combination product: No
  • HCT/P: No
  • Serial number: No
  • Expiration date: No