Clearance Summary
TUF-COAT received FDA 510(k) clearance under submission number K892806, sponsored by G-C Intl. 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 1989-07-14.
- Submission: K892806
- Applicant / Sponsor: G-C Intl. Corp.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3920
- Decision date: 1989-07-14
Classification & Regulation
This clearance is catalogued under FDA product code ELL and 21 CFR 872.3920, within the Dental review panel as a Class II device.