The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares Golden Ti/tin Abutments.
| Device ID | K162848 |
| 510k Number | K162848 |
| Device Name: | Straumann CARES Golden Ti/TiN Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | INSTITUT STRAUMANN AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Christopher Klaczyk |
| 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 | 2016-10-11 |
| Decision Date | 2017-09-22 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031732903 | K162848 | 000 |
| 07630031732897 | K162848 | 000 |
| 07630031732880 | K162848 | 000 |
| 07630031732873 | K162848 | 000 |
| 07630031732866 | K162848 | 000 |