The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Key Laser 1242.
| Device ID | K983100 |
| 510k Number | K983100 |
| Device Name: | KAVO KEY LASER 1242 |
| Classification | Powered Laser Surgical Instrument |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | Douglas Cochrane |
| Correspondent | Douglas Cochrane KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Product Code | GEX |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1998-09-03 |
| Decision Date | 1999-01-27 |
| Summary: | summary |