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Var-18-331

by GNI Co., Ltd

Var-18-331 is a self-ligating orthodontic bracket (FDA Class II; FDA product code NJM, Bracket, Ceramic, Orthodontic) made by GNI Co., Ltd, cleared under FDA 510(k) K201410 on 12 Mar 2021 and listed in FDA GUDID since 14 Dec 2022 (UDI-DI 08800046016032), active as of 20 Oct 2026.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 20 Oct 2026

Documents

510(k) K201410

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 20 Oct 2026.

Regulatory status

as of registry sync 20 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800046016032 UDI-DI Date14 Dec 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK201410 Date12 Mar 2021DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K201410 decided 12 Mar 2021 Active
  • FDA GUDID UDI-DI 08800046016032 listed 14 Dec 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K201410
  2. Listed FDA GUDID 08800046016032

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Generic name
Self-ligating orthodontic bracket
Model / reference
VAR-18-331
Primary DI / UDI-DI
08800046016032
510(k) Number
FDA product code
NJM
GMDN term
Self-ligating orthodontic bracket
Device class
Class II
Regulation number
872.5470
GUDID distribution status
In Commercial Distribution

Related devices

Category: Self-ligating orthodontic bracket

Cleared under the same submission (K201410)

and 8 more cleared under K201410

Similar devices in this category

Other devices filed under Self-ligating orthodontic bracket.

Other devices from GNI Co., Ltd

  • M1E-18-301

    Class I

  • Var-22-501

    Class II

  • SA1208C

    Class II

  • Rcr-18-503

    Class II

See all devices from GNI Co., Ltd →

Properties

  • Single use
  • Convenience kit
  • Lot / batch number
  • Manufacturing date
Other properties (11, all answered No)