The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Art Abutments.
| Device ID | K061807 |
| 510k Number | K061807 |
| Device Name: | SPI ART ABUTMENTS |
| Classification | Abutment, 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-06-27 |
| Decision Date | 2006-07-31 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156476545 | K061807 | 000 |
| 07640156476538 | K061807 | 000 |
| 07640156476507 | K061807 | 000 |
| 07640156476491 | K061807 | 000 |