The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Pure Ceramic Implant System.
| Device ID | K180477 |
| 510k Number | K180477 |
| Device Name: | Straumann PURE Ceramic Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH Ch-4002 |
| Contact | Pierre-yves Calinon |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-02-22 |
| Decision Date | 2019-01-04 |
| Summary: | summary |