Clearance Summary
COLTENE ORALLY received FDA 510(k) clearance under submission number K810907, 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 1981-04-23.
- Submission: K810907
- Applicant / Sponsor: Coltene, Inc.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class II
- Regulation citation: 21 CFR 872.3070
- Decision date: 1981-04-23
Classification & Regulation
This clearance is catalogued under FDA product code EJJ and 21 CFR 872.3070, within the Dental review panel as a Class II device.