The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Spi Vario Angled Abutment.
| Device ID | K111984 |
| 510k Number | K111984 |
| Device Name: | SPI VARIO ANGLED ABUTMENT |
| 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 | 2011-07-12 |
| Decision Date | 2011-11-10 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156472493 | K111984 | 000 |
| 07640156472240 | K111984 | 000 |
| 07640156472233 | K111984 | 000 |
| 07640156472226 | K111984 | 000 |
| 07640156472219 | K111984 | 000 |
| 07640156472202 | K111984 | 000 |
| 07640156472196 | K111984 | 000 |
| 07640156472189 | K111984 | 000 |
| 07640156472172 | K111984 | 000 |