Clearance Summary
SANI-DENT DENTURE CLEANER received FDA 510(k) clearance under submission number K781779, sponsored by Sandi-Dent. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1978-11-08.
- Submission: K781779
- Applicant / Sponsor: Sandi-Dent
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3530
- Decision date: 1978-11-08
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.