Clearance Summary
TOOTHBRUSH, PLAK-A-DENT received FDA 510(k) clearance under submission number K770464, sponsored by Smith, Ranscht, Pollock, Manos & Connor. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1977-04-08.
- Submission: K770464
- Applicant / Sponsor: Smith, Ranscht, Pollock, Manos & Connor
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1977-04-08
Classification & Regulation
This clearance is catalogued under FDA product code EFW and 21 CFR 872.6855, within the Dental review panel as a Class I device.