The following data is part of a premarket notification filed by Thommen Medical, Ag with the FDA for Varioeco.
| Device ID | K121334 |
| 510k Number | K121334 |
| Device Name: | VARIOECO |
| Classification | Abutment, Implant, Dental, Endosseous |
| 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 | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-05-03 |
| Decision Date | 2012-08-14 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07640156472110 | K121334 | 000 |
| 07640156472035 | K121334 | 000 |
| 07640156472042 | K121334 | 000 |
| 07640156472059 | K121334 | 000 |
| 07640156472066 | K121334 | 000 |
| 07640156472073 | K121334 | 000 |
| 07640156472080 | K121334 | 000 |
| 07640156472097 | K121334 | 000 |
| 07640156472103 | K121334 | 000 |
| 07640156472028 | K121334 | 000 |