ProMonitoring FGS-2008
ProMonitoring FGS-2008 is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Candid Care Co., cleared under FDA 510(k) K190948 on 9 May 2019 and listed in FDA GUDID since 27 Jul 2026 (UDI-DI 00850004223352), 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 | Number00850004223352 | Date27 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190948 | Date9 May 2019 | StatusActive |
Official records
- AccessGUDID record 00850004223352
- FDA 510(k) database K190948
Across registries
- FDA 510(k) K190948 decided 9 May 2019 Active
- FDA GUDID UDI-DI 00850004223352 listed 27 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K190948
- Listed FDA GUDID 00850004223352
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- ProMonitoring
- Generic name
- Orthodontic progressive aligner
- Model / reference
- FGS-2008
- Primary DI / UDI-DI
- 00850004223352
- 510(k) Number
- FDA product code
- NXC
- GMDN term
- Orthodontic progressive aligner
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- In Commercial Distribution
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- DynaFlex by Dyna Flex
- Angel Align System by Smile Development Corp
- ZSmile System by Dror Orthodesign, Ltd.
- OSW Aligner System by Osw Manufacturing, LLC
- Tera Harz Clear Aligner by Graphy Inc.
- Ensmile by Ensmile Pvt, Ltd.
- Spark Clear Aligner System by Ormco Corporation
- Smylic Invisible Clear Aligners by SMYLIO
- Serafin® by Tns Co., Ltd.
- TERA HARZ CLEAR TA-28 NONE by Graphy Inc.