The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Boneceramic.
| Device ID | K201051 |
| 510k Number | K201051 |
| Device Name: | Straumann BoneCeramic |
| Classification | Bone Grafting Material, Synthetic |
| Applicant | Institut Straumann AG Peter Merian-Weg 12 Basel, CH Ch-4002 |
| Contact | Christelle Gerspach-gasser |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | LYC |
| CFR Regulation Number | 872.3930 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-04-21 |
| Decision Date | 2020-09-24 |