510(k) K863097
K863097 is an FDA 510(k) premarket notification submitted by Beavers Dental, Div. Sybron Canada, Ltd. for the device "CB BUR". The FDA issued a decision of Substantially Equivalent on August 26, 1986. The device falls under product code EJL (Bur, Dental), a Class I device regulated under 21 CFR 872.3240. Beavers Dental, Div. Sybron Canada, Ltd. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 26, 1986
- Date Received
- August 14, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Bur, Dental
- Device Class
- Class I
- Regulation Number
- 872.3240
- Review Panel
- DE
- Submission Type