Data / Medical devices / Germany / Bego Implant Systems GMBH & Co. KG
Bego Implant Systems GMBH & Co. KG: FDA-registered device maker in Bremen, Germany, 2 510(k) clearances
Bego Implant Systems GMBH & Co. KG is registered with the FDA (registration 3008252251) in Bremen, Germany. It lists 5 device types. The FDA files 2 510(k) clearances under its listings, the newest dated February 18, 2021. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3008252251
- Address
- Wilhelm-Herbst-Str. 1, Bremen, Germany, 28359
- Owner or operator
- BEGO Implant Systems GmbH & Co. KG (10028893)
- Roles
- Manufacturer
- First device listed
- October 9, 2017
- Registered through
- 2026
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Abutment, Implant, Dental, Endosseous | NHA | 2 | Manufacturer | accessdata.fda.gov |
| Accessories, Implant, Dental, Endosseous | NDP | 1 | Manufacturer | accessdata.fda.gov |
| Implant, Endosseous, Root-Form | DZE | 2 | Manufacturer | accessdata.fda.gov |
| Sterilization Wrap Containers, Trays, Cassettes & Other Accessories | KCT | 2 | Manufacturer | accessdata.fda.gov |
| Tray, Impression, Preformed | EHY | 1 | Manufacturer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| February 18, 2021 | K201412 | BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit | KCT | Substantially Equivalent | Bego Implant Systems GmbH & Co. KG | accessdata.fda.gov |
| January 13, 2021 | K201700 | BEGO Semados® RS/RSX Implant System | DZE | Substantially Equivalent | Bego Implant Systems GmbH & Co. KG | accessdata.fda.gov |
Compare with other makers
- All makers of Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
- All makers of Implant, Endosseous, Root-Form
- All makers of Abutment, Implant, Dental, Endosseous
- All makers of Accessories, Implant, Dental, Endosseous
- All makers of Tray, Impression, Preformed
Updated February 18, 2021. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.