Clearance Summary
Dental Unit received FDA 510(k) clearance under submission number K142206, sponsored by Zhuhai Siger 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 2015-03-13.
- Submission: K142206
- Applicant / Sponsor: Zhuhai Siger Medical Equipment Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6640
- Decision date: 2015-03-13
Classification & Regulation
This clearance is catalogued under FDA product code EIA and 21 CFR 872.6640, within the Dental review panel as a Class I device.