Vatech Clismile 12-1211
Vatech Clismile 12-1211 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 08800018601389), active as of 23 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number08800018601389 | Date31 May 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK220689 | Date6 May 2022 | StatusActive |
Official records
- AccessGUDID record 08800018601389
- FDA 510(k) database K220689
Across registries
- FDA 510(k) K220689 decided 6 May 2022 Active
- FDA GUDID UDI-DI 08800018601389 listed 31 May 2022 Listed
Timeline
- Cleared FDA 510(k) K220689
- Listed FDA GUDID 08800018601389
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Vatech Clismile
- Generic name
- Orthodontic bracket, ceramic
- Model / reference
- 12-1211
- Primary DI / UDI-DI
- 08800018601389
- 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
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