The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Intrasept 905.
| Device ID | K934783 |
| 510k Number | K934783 |
| Device Name: | KAVO INTRASEPT 905 |
| Classification | Unit, Operative Dental |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | Edward Stogenson |
| Correspondent | Edward Stogenson KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Product Code | EIA |
| CFR Regulation Number | 872.6640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-10-06 |
| Decision Date | 1994-05-16 |