ClearCorrect System Engager Template
ClearCorrect System Engager Template (REF-02), an orthodontic resin positioning tray (FDA Class II; FDA product code NXC, Aligner, Sequential) made by ClearCorrect Operating LLC, was listed in FDA GUDID on 23 Jul 2020 (UDI-DI D865REF00021); the registry lists it as not in commercial distribution (GUDID) 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 | NumberD865REF00021 | Date23 Jul 2020 | StatusListed |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — GUDID listing Listed
Specification
- Trade name
- ClearCorrect System
- Generic name
- Orthodontic resin positioning tray
- Model / Ref / Catalog
- Engager Template, REF-02
- Primary DI / UDI-DI
- D865REF00021
- FDA product code
- NXC
- GMDN term
- Orthodontic resin positioning tray
- Device class
- Class II
- Regulation number
- 872.5470
- GUDID distribution status
- Not in Commercial Distribution
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