The following data is part of a premarket notification filed by Astra Tech Ab with the FDA for Osseospeed Angled Abutment Ev.
| Device ID | K121810 |
| 510k Number | K121810 |
| Device Name: | OSSEOSPEED ANGLED ABUTMENT EV |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | ASTRA TECH AB 11234 EL CAMINO REAL, SUITE 200 San Diego, CA 92130 |
| Contact | Linda K Schulz |
| Correspondent | Linda K Schulz ASTRA TECH AB 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 | 2012-06-20 |
| Decision Date | 2013-01-23 |
| Summary: | summary |