Clearance Summary
CUPRIDENT received FDA 510(k) clearance under submission number K851073, sponsored by Bio Systems, 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 1985-07-31.
- Submission: K851073
- Applicant / Sponsor: Bio Systems, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6030
- Decision date: 1985-07-31
Classification & Regulation
This clearance is catalogued under FDA product code EJR and 21 CFR 872.6030, within the Dental review panel as a Class I device.