The following data is part of a premarket notification filed by Vermont Diamond Instruments with the FDA for Smart Burs Total Carbides.
| Device ID | K920243 |
| 510k Number | K920243 |
| Device Name: | SMART BURS TOTAL CARBIDES |
| Classification | Bur, Dental |
| Applicant | VERMONT DIAMOND INSTRUMENTS P.O. BOX 147 RIVER ROAD Bridgewater Corners, VT 05035 |
| Contact | Larry Clark |
| Correspondent | Larry Clark VERMONT DIAMOND INSTRUMENTS P.O. BOX 147 RIVER ROAD Bridgewater Corners, VT 05035 |
| Product Code | EJL |
| CFR Regulation Number | 872.3240 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-01-17 |
| Decision Date | 1992-03-25 |