Clearance Summary
SCHERER PORTABLE TOOTH POLISHER received FDA 510(k) clearance under submission number K860264, sponsored by Scherer Laboratories, 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 1986-06-26.
- Submission: K860264
- Applicant / Sponsor: Scherer Laboratories, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6865
- Decision date: 1986-06-26
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.