Clearance Summary
TOP FORM II TRAYS, DISPOS FOAM-LINED TOP GEL APPLI received FDA 510(k) clearance under submission number K871784, sponsored by Colgate-Hoyt Laboratories. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1987-05-27.
- Submission: K871784
- Applicant / Sponsor: Colgate-Hoyt Laboratories
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.6870
- Decision date: 1987-05-27
Classification & Regulation
This clearance is catalogued under FDA product code KMT and 21 CFR 872.6870, within the Dental review panel as a Class I device.