Data / Medical devices / Germany / Botiss Biomaterials GMBH
Botiss Biomaterials GMBH: FDA-registered device maker in Zossen Brandenburg, Germany, 3 510(k) clearances
Botiss Biomaterials GMBH is registered with the FDA (registration 3014206569) in Zossen Brandenburg, Germany. It lists 2 device types. The FDA files 3 510(k) clearances under its listings, the newest dated December 12, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014206569
- Address
- Hauptstrasse 28, Zossen Brandenburg, Germany, 15806
- Owner or operator
- botiss biomaterials GmbH (10058419)
- Roles
- Complaint file establishment, Exporter to the US, Specification developer
- First device listed
- September 24, 2018
- Registered through
- 2026
- Brand names listed
- Jason membrane, Straumann Jason membrane, Straumann cerabone, cerabone
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Barrier, Animal Source, Intraoral | NPL | 2 | Complaint file establishment, Exporter to the US, Specification developer | accessdata.fda.gov |
| Bone Grafting Material, Animal Source | NPM | 2 | Complaint file establishment, Exporter to the US, Specification developer | 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 |
|---|---|---|---|---|---|---|
| December 12, 2025 | K242817 | Jason membrane | NPL | Substantially Equivalent | Botiss Biomaterials GmbH | accessdata.fda.gov |
| October 19, 2018 | K173594 | Straumann cerabone | NPM | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
| July 9, 2018 | K173562 | Straumann Jason Membrane | NPL | Substantially Equivalent | Institut Straumann AG | accessdata.fda.gov |
Compare with other makers
Updated December 12, 2025. 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.