Clearance Summary
COLTENE COLTEX/COLTOFLAX received FDA 510(k) clearance under submission number K811666, sponsored by Coltene, Inc.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1981-07-15.
- Submission: K811666
- Applicant / Sponsor: Coltene, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3660
- Decision date: 1981-07-15
Classification & Regulation
This clearance is catalogued under FDA product code ELW and 21 CFR 872.3660, within the Dental review panel as a Class II device.