Clearance Summary
PORTA-PRO TOOTH POLISHER received FDA 510(k) clearance under submission number K770116, sponsored by Porta-Pro, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-01-28.
- Submission: K770116
- Applicant / Sponsor: Porta-Pro, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1977-01-28
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.