The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Contact Dental Implant.
| Device ID | K034014 |
| 510k Number | K034014 |
| Device Name: | SPI CONTACT DENTAL IMPLANT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Contact | Floyd G Larson |
| Correspondent | Floyd G Larson THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-12-24 |
| Decision Date | 2004-03-05 |
| Summary: | summary |