CandidPro FGS-0004
CandidPro FGS-0004 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 00850004223260), 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 | Number00850004223260 | Date27 Jul 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190948 | Date9 May 2019 | StatusActive |
Official records
- AccessGUDID record 00850004223260
- FDA 510(k) database K190948
Across registries
- FDA 510(k) K190948 decided 9 May 2019 Active
- FDA GUDID UDI-DI 00850004223260 listed 27 Jul 2026 Listed
Timeline
- Cleared FDA 510(k) K190948
- Listed FDA GUDID 00850004223260
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- CandidPro
- Generic name
- Orthodontic progressive aligner
- Model / reference
- FGS-0004
- Primary DI / UDI-DI
- 00850004223260
- 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
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- LuxCreo Clear Aligner System by LuxCreo, Inc.