Clearance Summary
TOOTH SLOOTH received FDA 510(k) clearance under submission number K833338, sponsored by Joel Lander D.D.S.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1983-11-25.
- Submission: K833338
- Applicant / Sponsor: Joel Lander D.D.S.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.4565
- Decision date: 1983-11-25
Classification & Regulation
This clearance is catalogued under FDA product code EJB and 21 CFR 872.4565, within the Dental review panel as a Class I device.