Clearance Summary
ENAMEL BONDING SYSTEM received FDA 510(k) clearance under submission number K020050, sponsored by Rite-Dent Manufacturing 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 2002-02-14.
- Submission: K020050
- Applicant / Sponsor: Rite-Dent Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3200
- Decision date: 2002-02-14
Classification & Regulation
This clearance is catalogued under FDA product code KLE and 21 CFR 872.3200, within the Dental review panel as a Class II device.