The following data is part of a premarket notification filed by Beavers Dental, Div. Sybron Canada, Ltd. with the FDA for Beavers' Dental Diamond Instruments.
| Device ID | K880179 |
| 510k Number | K880179 |
| Device Name: | BEAVERS' DENTAL DIAMOND INSTRUMENTS |
| Classification | Instrument, Diamond, Dental |
| Applicant | BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. ONE THOMAS CIRCLE Washington, DC 20005 |
| Contact | Kurzman, Pc |
| Correspondent | Kurzman, Pc BEAVERS DENTAL, DIV. SYBRON CANADA, LTD. ONE THOMAS CIRCLE Washington, DC 20005 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-01-13 |
| Decision Date | 1988-03-09 |