The following data is part of a premarket notification filed by Straumann Usa, Llc with the FDA for Straumann Screw-retained Abutment.
| Device ID | K150814 |
| 510k Number | K150814 |
| Device Name: | Straumann Screw-Retained Abutment |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Contact | Manuela Ventur |
| Correspondent | Christopher Klaczyk STRAUMANN USA, LLC 60 MINUTEMAN ROAD Andover, MA 01810 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-27 |
| Decision Date | 2015-08-10 |
| Summary: | summary |