The following data is part of a premarket notification filed by Institut Straumann Ag with the FDA for Straumann Tlx Implant System.
| Device ID | K200586 |
| 510k Number | K200586 |
| Device Name: | Straumann TLX Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | Institut Straumann AG Peter Merian Weg 12 Basel, CH 4002 |
| Contact | Renate Reiss |
| Correspondent | Jennifer M Jackson Straumann USA, LLC 60 Minuteman Road Andover, MA 01810 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-03-06 |
| Decision Date | 2020-08-20 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07630031747259 | K200586 | 000 |
| 07630031747242 | K200586 | 000 |
| 07630031746221 | K200586 | 000 |
| 07630031746214 | K200586 | 000 |