The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Variobase For Bridge/bar Cylindrical.
| Device ID | K173968 |
| 510k Number | K173968 |
| Device Name: | Straumann Variobase For Bridge/Bar Cylindrical |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Lochhamer Schlag 6 Gräfelfing, DE 82166 |
| Contact | Gordon Dodds |
| Correspondent | Jennifer M Jackson Institut Straumann AG 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 | 2017-12-29 |
| Decision Date | 2018-07-17 |
| Summary: | summary |