Clearance Summary
DENTA PLUS received FDA 510(k) clearance under submission number K883403, sponsored by Connoisseurs Products Corp.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1988-10-25.
- Submission: K883403
- Applicant / Sponsor: Connoisseurs Products Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3530
- Decision date: 1988-10-25
Classification & Regulation
This clearance is catalogued under FDA product code JER and 21 CFR 872.3530, within the Dental review panel as a Class I device.