Unismile Clear Aligner Aligners
Unismile Clear Aligner Aligners is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Vitang Technology LLC, cleared under FDA 510(k) K191837 on 29 Jan 2020 and listed in FDA GUDID since 14 Oct 2024 (UDI-DI 00860012674619), active as of 22 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 | Number00860012674619 | Date14 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191837 | Date29 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 00860012674619
- FDA 510(k) database K191837
Across registries
- FDA 510(k) K191837 decided 29 Jan 2020 Active
- FDA GUDID UDI-DI 00860012674619 listed 14 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K191837
- Listed FDA GUDID 00860012674619
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unismile Clear Aligner
- Generic name
- Orthodontic progressive aligner
- Model / reference
- Aligners
- Primary DI / UDI-DI
- 00860012674619
- 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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