Clearance Summary
ELECTRO FLOSS received FDA 510(k) clearance under submission number K930178, sponsored by Arizona Implant Dentistry. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1993-07-28.
- Submission: K930178
- Applicant / Sponsor: Arizona Implant Dentistry
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6650
- Decision date: 1993-07-28
Classification & Regulation
This clearance is catalogued under FDA product code JET and 21 CFR 872.6650, within the Dental review panel as a Class I device.