Clearance Summary
Dental high speed handpiece, Dental low speed handpiece received FDA 510(k) clearance under submission number K181900, sponsored by Foshan Cicada Dental Instrument 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 2019-12-09.
- Submission: K181900
- Applicant / Sponsor: Foshan Cicada Dental Instrument Co, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2019-12-09
Classification & Regulation
This clearance is catalogued under FDA product code EFB and 21 CFR 872.4200, within the Dental review panel as a Class I device.