The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Dental Implant, Element.
| Device ID | K093615 |
| 510k Number | K093615 |
| Device Name: | SPI DENTAL IMPLANT, ELEMENT |
| Classification | Implant, Endosseous, Root-form |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, STE. 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz 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 | 2009-11-23 |
| Decision Date | 2010-03-04 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640182643959 | K093615 | 000 |
| 07640182643669 | K093615 | 000 |
| 07640182643607 | K093615 | 000 |
| 07640182643522 | K093615 | 000 |
| 07640182643461 | K093615 | 000 |
| 07640182643409 | K093615 | 000 |