Clearance Summary
Argen Clear Aligner, Argen Clear Aligner Premium received FDA 510(k) clearance under submission number K192846, sponsored by Argen Corporation. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2020-02-10.
- Submission: K192846
- Applicant / Sponsor: Argen Corporation
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5470
- Decision date: 2020-02-10
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.