sureclear template 2000
sureclear template 2000, an orthodontic progressive aligner (FDA Class II; FDA product code NXC, Aligner, Sequential) made by Orametrix, Inc., was cleared under FDA 510(k) K171860 on 5 Jan 2018 and listed in FDA GUDID on 5 Mar 2018 (UDI-DI 00856379007016); the registry lists it as not in commercial distribution (GUDID) 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 | Number00856379007016 | Date5 Mar 2018 | StatusListed |
| United States | FDA 510(k)SESE | NumberK171860 | Date5 Jan 2018 | StatusActive |
Official records
- AccessGUDID record 00856379007016
- FDA 510(k) database K171860
Across registries
- FDA 510(k) K171860 decided 5 Jan 2018 Active
- FDA GUDID UDI-DI 00856379007016 listed 5 Mar 2018 Listed
Timeline
- Cleared FDA 510(k) K171860
- Listed FDA GUDID 00856379007016
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- Trade name
- sureclear template
- Generic name
- Orthodontic progressive aligner
- Model / reference
- 2000
- Primary DI / UDI-DI
- 00856379007016
- 510(k) Number
- FDA product code
- NXC
- GMDN term
- Orthodontic progressive aligner
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- Not in Commercial Distribution
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