The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Titanium Base For Cad/cam.
| Device ID | K102804 |
| 510k Number | K102804 |
| Device Name: | SPI TITANIUM BASE FOR CAD/CAM |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz THOMMEN MEDICAL, AG 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-27 |
| Decision Date | 2011-04-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156472424 | K102804 | 000 |
| 07640156472349 | K102804 | 000 |
| 07640156472356 | K102804 | 000 |
| 07640156472363 | K102804 | 000 |
| 07640156472370 | K102804 | 000 |
| 07640156472387 | K102804 | 000 |
| 07640156472394 | K102804 | 000 |
| 07640156472400 | K102804 | 000 |
| 07640156472417 | K102804 | 000 |
| 07640156472332 | K102804 | 000 |