The following data is part of a premarket notification filed by Beavers Dental, Div. Sybron Canada, Ltd. with the FDA for Bluwhite Diamond Dental Burs Modified.
| Device ID | K120037 |
| 510k Number | K120037 |
| Device Name: | BLUWHITE DIAMOND DENTAL BURS MODIFIED |
| Classification | Instrument, Diamond, Dental |
| Applicant | BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Contact | Wendy Garman |
| Correspondent | Wendy Garman BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. 1717 WEST COLLINS AVENUE Orange, CA 92867 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-01-05 |
| Decision Date | 2012-04-20 |