Clearance Summary
Clear Aligner received FDA 510(k) clearance under submission number K203688, sponsored by Wuxi EA Medical Instruments Technologies Limited.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-10-08.
- Submission: K203688
- Applicant / Sponsor: Wuxi EA Medical Instruments Technologies Limited.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2021-10-08
Classification & Regulation
This clearance is catalogued under FDA product code NXC and 21 CFR 872.5470, within the Dental review panel as a Class II device.