Clearance Summary
Advanced Dental Appliance received FDA 510(k) clearance under submission number K203462, sponsored by Dasoft Partners. The device was reviewed via the Abbreviated premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2021-02-19.
- Submission: K203462
- Applicant / Sponsor: Dasoft Partners
- Clearance pathway: Abbreviated
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.5570
- Decision date: 2021-02-19
Classification & Regulation
This clearance is catalogued under FDA product code LRK and 21 CFR 872.5570, within the Dental review panel as a Class II device.