The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Cares Screw-retained Bridges And Bars.
| Device ID | K190097 |
| 510k Number | K190097 |
| Device Name: | Straumann CARES Screw-Retained Bridges And Bars |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH Ch-4002 |
| Contact | Gordon Dodds |
| 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 | 2019-01-22 |
| Decision Date | 2019-06-26 |