Clearance Summary
CB BUR received FDA 510(k) clearance under submission number K863097, sponsored by Beavers Dental, Div. Sybron Canada, Ltd.. The device was reviewed via the Traditional premarket notification pathway and assigned to the Dental review panel. The statutory decision date of record is 1986-08-26.
- Submission: K863097
- Applicant / Sponsor: Beavers Dental, Div. Sybron Canada, Ltd.
- Clearance pathway: Traditional
- Review panel: Dental
- Device class: Class I
- Regulation citation: 21 CFR 872.3240
- Decision date: 1986-08-26
Classification & Regulation
This clearance is catalogued under FDA product code EJL and 21 CFR 872.3240, within the Dental review panel as a Class I device.