Manufacturer registered with FDA
botiss biomaterials GmbH
Zossen, Germany. Lists 2 dental device types with FDA across 2 registered establishments, and holds 1 510(k) clearance as applicant.
- Device types listed
- 2
- Brands and models
- 4
- 510(k) clearances
- 12025–2025
- Markets registered in
- 1594 registrations outside the US
- Establishments
- 2Germany
510(k) clearances per year, 2007–2026
Registered in 15 markets
Where regulators' registries name botiss biomaterials GmbH as the manufacturer or the registration holder of a device.
| Market | Regulator | Named as | Name on the registry | Registrations | Issued | Records |
|---|---|---|---|---|---|---|
| United States | FDA | Manufacturer | botiss biomaterials GmbH | 1 clearances | 2025–2025 | Below |
| Colombia | INVIMA | Manufacturer | BOTISS BIOMATERIALS GMBHMEBIOS GMBH | 23 | — | Pure Global AI |
| Serbia | ALIMS | Manufacturer | botiss biomaterials GmbH | 11 | 2025–2025 | Pure Global AI |
| Australia | TGA | Manufacturer | Botiss Biomaterials GmbH | 9 | 2018–2026 | Pure Global AI |
| United Kingdom | MHRA | Manufacturer | botiss biomaterials GmbH | 9 | — | Pure Global AI |
| Israel | AMAR | Manufacturer | Botiss Biomaterials Gmbhmebios Gmbh | 7 | — | Pure Global AI |
| Saudi Arabia | SFDA | Manufacturer | Botiss Biomaterials GmbHmebios GmbH · mebios Gmbh | 7 | — | Pure Global AI |
| Canada | Health Canada | Registration holder | BOTISS BIOMATERIALS GMBH | 6 | 2018–2026 | Pure Global AI |
| Taiwan | TFDA | Manufacturer | BOTISS BIOMATERIALS GMBHBotiss Biomaterials GmbH · mebios GmbH | 6 | 2013–2025 | Pure Global AI |
| Peru | DIGEMID | Manufacturer | BOTISS BIOMATERIALS GMBH | 5 | 2023–2024 | Pure Global AI |
| Costa Rica | Ministerio de Salud | Manufacturer | BOTISS BIOMATERIALS GmBHbotiss biomaterials GmbH | 4 | — | Pure Global AI |
| Brazil | ANVISA | Manufacturer | BOTISS BIOMATERIALS GMBH | 3 | 2024–2025 | Pure Global AI |
| China | NMPA | Registration holder | 骨力士生物材料股份有限公司botiss biomaterials GmbH | 2 | — | Pure Global AI |
| European Union | EUDAMED | Manufacturer | botiss biomaterials GmbH | 1 | — | Pure Global AI |
| South Korea | MFDS | Manufacturer | mebios GmbH | 1 | 2011–2011 | Pure Global AI |
Outside the US the count is of all the company's device registrations in that market, dental or not · matched by company name and country · registry data read 12 Nov 2026
Devices listed with FDA
What botiss biomaterials GmbH currently lists, by FDA device type, with the brand and model names on the listing.
| Device type | Category | Role | Brands and models | Listed since |
|---|---|---|---|---|
| Intraoral Animal Source BarrierNPL · Class 2 | Bone grafts & membranes | Maker | Jason membraneStraumann Jason membrane | 2018 |
| Animal Source Bone Grafting MaterialNPM · Class 2 | Bone grafts & membranes | Maker | ceraboneStraumann cerabone | 2018 |
Source: FDA establishment registration & device listing, 510(k) and product classification files · FDA data as of 2 Nov 2026 · snapshot 12 Nov 2026
Also lists devices cleared under other names
botiss biomaterials GmbH lists these devices with FDA today. The clearance names a different applicant, as happens after a rename, an acquisition or a private-label agreement.
Original applicants: Institut Straumann AG (2).
| Decided | 510(k) | Device | Applicant | Device type |
|---|---|---|---|---|
| 19 Oct 2018 | K173594 | Straumann cerabone | Institut Straumann AG | NPM Animal Source Bone Grafting Material |
| 9 Jul 2018 | K173562 | Straumann Jason Membrane | Institut Straumann AG | NPL Intraoral Animal Source Barrier |
Registered establishments
| Establishment | Location | What it does |
|---|---|---|
| BOTISS BIOMATERIALS GMBHFDA reg. 3014206569 | Zossen Brandenburg, Germany | Complaint file establishment, Foreign exporter, Specification developer |
| mebios GmbHFDA reg. 3015131160 | Dieburg Hesse, Germany | Contract manufacturer |
Other names on FDA records
mebios GmbH
Sources
FDA establishment registration & device listing (search FDA, owner/operator 10058419). FDA 510(k) premarket notification file. FDA data as of 2 Nov 2026; snapshot 12 Nov 2026. The location shown is the address on FDA's record.