3M™ Clarity™ 358-509
3M Clarity 358-509 is an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by 3M Unitek Corporation, listed in FDA GUDID since 29 Jun 2020 (UDI-DI 00652221289537), registry data as of 22 Oct 2026.
Listed
Valid until
Not applicable
FDA recalls
Not checked
Documents
None
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | GUDID listing | Number00652221289537 | Date29 Jun 2020 | StatusListed |
Official records
- AccessGUDID record 00652221289537
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- 3M™ Clarity™
- Generic name
- Orthodontic progressive aligner
- Model / Ref / Catalog
- 358-509
- Primary DI / UDI-DI
- 00652221289537
- 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).
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- Smylio Invisible Clear Aligners by SMYLIO
- Smylio Aligners by SMYLIO
- Primeprint Direct Aligner by Dreve Dentamid GmbH
- Custom Clear Aligner System by Derby Dental Laboratory
- SmileAlign Orthodontic Aligner System by 3D Global Biotech, Inc.
- MTM CLEAR ALIGNER IN-OFFICE by Dentsply International