Clearance Summary
SAFE TDENT received FDA 510(k) clearance under submission number K820245, sponsored by Professional Dental Studios. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1982-04-09.
- Submission: K820245
- Applicant / Sponsor: Professional Dental Studios
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3570
- Decision date: 1982-04-09
Classification & Regulation
This clearance is catalogued under FDA product code EBO and 21 CFR 872.3570, within the Dental review panel as a Class II device.