Clearance Summary
TOOTHBRUSH received FDA 510(k) clearance under submission number K760512, sponsored by Asset Scientific & Pharmaceutical, 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 1976-09-03.
- Submission: K760512
- Applicant / Sponsor: Asset Scientific & Pharmaceutical, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6855
- Decision date: 1976-09-03
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.