The following data is part of a premarket notification filed by Beavers Dental, Div. Sybron Canada, Ltd. with the FDA for Cb Bur.
| Device ID | K863097 |
| 510k Number | K863097 |
| Device Name: | CB BUR |
| Classification | Bur, Dental |
| Applicant | BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. NIXON,HARGRAVE,DEVANS & DOYLE SUITE 800, ONE THOMAS CIRCLE Washington, DC 20005 |
| Contact | Stephen Kurzman |
| Correspondent | Stephen Kurzman BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. NIXON,HARGRAVE,DEVANS & DOYLE SUITE 800, ONE THOMAS CIRCLE Washington, DC 20005 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-08-14 |
| Decision Date | 1986-08-26 |