ClearCorrect System MFG-0101 1.0
ClearCorrect System MFG-0101 1.0 (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 8 Apr 2019 (UDI-DI D865REF0002); 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 | NumberD865REF0002 | Date8 Apr 2019 | 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- Withdrawn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
- MFG-0101 1.0, REF-02
- Primary DI / UDI-DI
- D865REF0002
- 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
Similar devices
Other devices filed under FDA product code NXC (Aligner, Sequential).
- Ensmile by Ensmile Pvt, Ltd.
- Spark Clear Aligner System by Ormco Corporation
- Smylic Invisible Clear Aligners by SMYLIO
- Serafin® by Tns Co., Ltd.
- TERA HARZ CLEAR TA-28 NONE by Graphy Inc.
- Sureclear aligners by Emergo Global Consulting, LLC
- Custom-made Invisible Aligners by Zhejiang Yinchili Medical Technology Co., Ltd.
- MTM(R) CLEAR ALIGNER by Dentsply International
- Arkligners by Arklign Laboratories
- SureCure Orthodontic Aligner System by Digital Orthodontic Care