Oliv FGS-3025
Oliv FGS-3025 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 14 Sep 2026 (UDI-DI 00850004223468), 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 | Number00850004223468 | Date14 Sep 2026 | StatusListed |
| United States | FDA 510(k)SESE | NumberK190948 | Date9 May 2019 | StatusActive |
Official records
- AccessGUDID record 00850004223468
- FDA 510(k) database K190948
Across registries
- FDA 510(k) K190948 decided 9 May 2019 Active
- FDA GUDID UDI-DI 00850004223468 listed 14 Sep 2026 Listed
Timeline
- Cleared FDA 510(k) K190948
- Listed FDA GUDID 00850004223468
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Oliv
- Generic name
- Orthodontic progressive aligner
- Model / reference
- FGS-3025
- Primary DI / UDI-DI
- 00850004223468
- 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).
- Clear Aligner by Wuxi EA Medical Instruments Technologies Limited.
- DenMat Orthodontic Aligners by Den-Mat Holdings, LLC
- LuxCreo Clear Aligner System by LuxCreo, Inc.
- Park Dental Research Aligners by Park Dental Research Corp
- Alien Aligners by ALIEN MILLING TECHNOLOGIES
- SmileSeries by Ordont Orthodontic Laboratories, Inc.
- Invisalign Pre-Formed Attachment System by Align Technology Inc.
- QuickAligners by Oral Image, Inc.
- Magic Clear Aligners by Voodoo Manufacturing, Inc.
- Custom-made Invisible Aligners by Zhejiang Yinchili Medical Technology Co., Ltd.