The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Vectodrill Ceramic Drills.
| Device ID | K070290 |
| 510k Number | K070290 |
| Device Name: | SPI VECTODRILL CERAMIC DRILLS |
| Classification | Accessories, Implant, Dental, Endosseous |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Contact | Floyd Larson |
| Correspondent | Floyd Larson THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Product Code | NDP |
| CFR Regulation Number | 872.3980 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-30 |
| Decision Date | 2007-04-17 |
| Summary: | summary |