Rcm-18-331
by GNI Co., Ltd
Rcm-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 15 Dec 2022 (UDI-DI 08800046017114), active as of 20 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 | Number08800046017114 | Date15 Dec 2022 | StatusListed |
| United States | FDA 510(k)SESE | NumberK201410 | Date12 Mar 2021 | StatusActive |
Official records
- AccessGUDID record 08800046017114
- FDA 510(k) database K201410
Across registries
- FDA 510(k) K201410 decided 12 Mar 2021 Active
- FDA GUDID UDI-DI 08800046017114 listed 15 Dec 2022 Listed
Timeline
- Cleared FDA 510(k) K201410
- Listed FDA GUDID 08800046017114
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Generic name
- Self-ligating orthodontic bracket
- Model / reference
- RCM-18-331
- Primary DI / UDI-DI
- 08800046017114
- 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
Similar devices in this category
Other devices filed under Self-ligating orthodontic bracket.