Clearance Summary
PLASTIC TOOTH REINFORCEMENT KIT received FDA 510(k) clearance under submission number K895758, sponsored by Nanzee Dental Products. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1989-12-20.
- Submission: K895758
- Applicant / Sponsor: Nanzee Dental Products
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3740
- Decision date: 1989-12-20
Classification & Regulation
This clearance is catalogued under FDA product code EBL and 21 CFR 872.3740, within the Dental review panel as a Class I device.