Clearance Summary
TOOTH SHADE RESIN MATERIAL received FDA 510(k) clearance under submission number K011453, 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 2001-07-23.
- Submission: K011453
- Applicant / Sponsor: Rite-Dent Manufacturing Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3690
- Decision date: 2001-07-23
Classification & Regulation
This clearance is catalogued under FDA product code EBF and 21 CFR 872.3690, within the Dental review panel as a Class II device.