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Vatech Clismile 12-1212

by Rayence Co., Ltd.

Vatech Clismile 12-1212 is an orthodontic bracket (FDA Class II; FDA product code NJM, Bracket, Ceramic, Orthodontic) made by Rayence Co., Ltd., cleared under FDA 510(k) K220689 on 6 May 2022 and listed in FDA GUDID since 31 May 2022 (UDI-DI 08800018601372), active as of 23 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 23 Oct 2026

Documents

510(k) K220689

FDA submission, from GUDID

Trust

Unverified

Source GUDID, synced 23 Oct 2026.

Regulatory status

as of registry sync 23 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesGUDID listing Number08800018601372 UDI-DI Date31 May 2022ListedStatusListed GUDID: in commercial distribution
United StatesFDA 510(k)SESE from GUDID Substantially Equivalent · Traditional NumberK220689 Date6 May 2022DecidedStatusActive

Official records

Across registries

2 registries list this device

  • FDA 510(k) K220689 decided 6 May 2022 Active
  • FDA GUDID UDI-DI 08800018601372 listed 31 May 2022 Listed

Timeline

2 dated events

  1. Cleared FDA 510(k) K220689
  2. Listed FDA GUDID 08800018601372

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Specification

GUDID

Trade name
Vatech Clismile
Generic name
Orthodontic bracket, ceramic
Model / reference
12-1212
Primary DI / UDI-DI
08800018601372
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

Category: Orthodontic bracket, ceramic

Cleared under the same submission (K220689)

and 8 more cleared under K220689

Similar devices

Other devices filed under FDA product code NJM (Bracket, Ceramic, Orthodontic).

Other devices from Rayence Co., Ltd.

See all devices from Rayence Co., Ltd. →

Properties

  • Single use
  • Prescription use
  • Combination product
  • Lot / batch number
  • Manufacturing date
Other properties (10, all answered No)