Clearance Summary
EMS AIR-FLOW HANDY 2 DENTAL HANDPIECE received FDA 510(k) clearance under submission number K022119, sponsored by Electro Medical Systems SA. The device was reviewed via the Special premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 2002-07-25.
- Submission: K022119
- Applicant / Sponsor: Electro Medical Systems SA
- Clearance pathway: Special
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4200
- Decision date: 2002-07-25
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.