The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Variobase For Crown As.
| Device ID | K173379 |
| 510k Number | K173379 |
| Device Name: | Straumann Variobase For Crown AS |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Lochhamer Schlag 6 Graefelfing, DE 82166 |
| 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 | 2017-10-30 |
| Decision Date | 2018-03-30 |
| Summary: | summary |