Unismile Clear Aligner Retainer
Unismile Clear Aligner Retainer is an orthodontic retainer (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 00860012674626), 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 | Number00860012674626 | Date14 Oct 2024 | StatusListed |
| United States | FDA 510(k)SESE | NumberK191837 | Date29 Jan 2020 | StatusActive |
Official records
- AccessGUDID record 00860012674626
- FDA 510(k) database K191837
Across registries
- FDA 510(k) K191837 decided 29 Jan 2020 Active
- FDA GUDID UDI-DI 00860012674626 listed 14 Oct 2024 Listed
Timeline
- Cleared FDA 510(k) K191837
- Listed FDA GUDID 00860012674626
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- Unismile Clear Aligner
- Generic name
- Orthodontic retainer
- Model / reference
- Retainer
- Primary DI / UDI-DI
- 00860012674626
- 510(k) Number
- FDA product code
- NXC
- GMDN term
- Orthodontic retainer
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- In Commercial Distribution
Similar devices in this category
Other devices filed under Orthodontic retainer.
- Universal Rotator Elastic - Crystal 60.07.200 by Dental Morelli Ltda
- Wire products for fixed orthodontic appliance C1211-30 by LEONE S.P.A.
- POWER CHAIN RUBY OPEN SPACE 639-0058 by Ormco Corporation
- POWER CHAIN EMERALD OPEN SPACE 639-0053 by Ormco Corporation
- Orthodontic elastic chains and ligatures K6466-13 by LEONE S.P.A.
- Elastomeric Separator 325-302 by G&H Wire Company, Inc.
- E-Z Tie Tubing 854-034069 by American Orthodontics
- Latex-Free Elastomeric Power Chain 60.62.300.23110 by World Class Technology Corporation
- Intraoral Elastic - "Silicone" - Medium 3/16" 60.08.111 by Dental Morelli Ltda
- Arch Wire Sleeve 854-540 by American Orthodontics