The following data is part of a premarket notification filed by Kavo America with the FDA for Kavo Key Laser 1242 And Kavo Key Laser 1243+.
| Device ID | K030146 |
| 510k Number | K030146 |
| Device Name: | KAVO KEY LASER 1242 AND KAVO KEY LASER 1243+ |
| Classification | Laser, Dental, Soft Tissue |
| Applicant | KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Contact | J0hn R Franz |
| Correspondent | J0hn R Franz KAVO AMERICA 340 EAST MAIN ST. Lake Zurich, IL 60047 |
| Product Code | NVK |
| CFR Regulation Number | 878.4810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-01-15 |
| Decision Date | 2005-08-03 |
| Summary: | summary |