The following data is part of a premarket notification filed by Straumann Usa, Llc (on Behalf Of Institut Straumann Ag) with the FDA for Straumann Screw Retained Abutments.
| Device ID | K171757 |
| 510k Number | K171757 |
| Device Name: | Straumann Screw Retained Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Straumann USA, LLC (on Behalf Of Institut Straumann AG) 60 Minuteman Road Andover, MA 01810 |
| Contact | Chanrasmey White |
| Correspondent | Jennifer M. Jackson 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 | 2017-06-14 |
| Decision Date | 2017-11-27 |
| Summary: | summary |