Clearance Summary
High-speed air turbine handpiece / Low-speed air turbine handpiece received FDA 510(k) clearance under submission number K181691, sponsored by Foshan Wenjian Medical 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 2020-05-26.
- Submission: K181691
- Applicant / Sponsor: Foshan Wenjian Medical Instrument Co., Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2020-05-26
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.