Clearance Summary
ROTA-DENT TOOTH CLEANER received FDA 510(k) clearance under submission number K880589, sponsored by Pro-Dentec. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-05-11.
- Submission: K880589
- Applicant / Sponsor: Pro-Dentec
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1988-05-11
Classification & Regulation
This clearance is catalogued under FDA product code JEQ and 21 CFR 872.6865, within the Dental review panel as a Class I device.