The following data is part of a premarket notification filed by Bego Implant Systems Gmbh & Co. Kg with the FDA for Bego Semados® Rs/rsx Implant System.
| Device ID | K201700 |
| 510k Number | K201700 |
| Device Name: | BEGO Semados® RS/RSX Implant System |
| Classification | Implant, Endosseous, Root-form |
| Applicant | BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
| Contact | Bertrand Lecointe |
| Correspondent | Bertrand Lecointe BEGO Implant Systems GmbH & Co. KG Wilhelm-Herbst-Str. 1 Bremen, DE 28359 |
| Product Code | DZE |
| CFR Regulation Number | 872.3640 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-22 |
| Decision Date | 2021-01-13 |