The following data is part of a premarket notification filed by Dunhall Pharmaceuticals, Inc. with the FDA for Dunhall/omnii International Rotary Diamond Burs.
| Device ID | K940908 |
| 510k Number | K940908 |
| Device Name: | DUNHALL/OMNII INTERNATIONAL ROTARY DIAMOND BURS |
| Classification | Instrument, Diamond, Dental |
| Applicant | DUNHALL PHARMACEUTICALS, INC. P.O. BOX 100 Gravette, AR 72736 |
| Contact | Monte J Staha |
| Correspondent | Monte J Staha DUNHALL PHARMACEUTICALS, INC. P.O. BOX 100 Gravette, AR 72736 |
| Product Code | DZP |
| CFR Regulation Number | 872.4535 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-02-24 |
| Decision Date | 1994-08-29 |