The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Element Platform O 4.0 Mm.
| Device ID | K070007 |
| 510k Number | K070007 |
| Device Name: | SPI ELEMENT PLATFORM O 4.0 MM |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-01-03 |
| Decision Date | 2007-01-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156476170 | K070007 | 000 |
| 07640156473049 | K070007 | 000 |