The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares M-series Cad/cam System.
| Device ID | K171649 |
| 510k Number | K171649 |
| Device Name: | Straumann CARES M-Series CAD/CAM System |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH 4002 |
| Contact | Andreas Petermann |
| 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 | 2017-06-05 |
| Decision Date | 2018-02-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031729637 | K171649 | 000 |
| 07630031755247 | K171649 | 000 |
| 07630031755254 | K171649 | 000 |
| 07630031755261 | K171649 | 000 |
| 07630031740762 | K171649 | 000 |
| 07630031740809 | K171649 | 000 |
| 07630031729552 | K171649 | 000 |
| 07630031729569 | K171649 | 000 |
| 07630031729620 | K171649 | 000 |
| 07899878028536 | K171649 | 000 |