Clearance Summary
HDR Sensor- HDR361 (Size 1), HDR Sensor- HDR461 (Size 2) received FDA 510(k) clearance under submission number K221008, sponsored by Shanghai Handy Medical Equipment Co., Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2022-06-22.
- Submission: K221008
- Applicant / Sponsor: Shanghai Handy Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.1800
- Decision date: 2022-06-22
Classification & Regulation
This clearance is catalogued under FDA product code MUH and 21 CFR 872.1800, within the Dental review panel as a Class II device.