Clearance Summary
DENTRAY II PLUS TRAY ADHESIVE received FDA 510(k) clearance under submission number K952930, sponsored by Confi-Dental Products Co.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1995-09-08.
- Submission: K952930
- Applicant / Sponsor: Confi-Dental Products Co.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1995-09-08
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.