The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Tlx Novaloc And Cementable Abutments.
| Device ID | K203355 |
| 510k Number | K203355 |
| Device Name: | Straumann TLX Novaloc And Cementable Abutments |
| Classification | Abutment, Implant, Dental, Endosseous |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH Ch-4002 |
| Contact | Laure Kuhner Borsenberger |
| Correspondent | Jennifer M. Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01801 |
| Product Code | NHA |
| CFR Regulation Number | 872.3630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-16 |
| Decision Date | 2021-02-12 |