Is this your brand? Sign in to claim ownership.
Sign in to claim this brandBotiss Biomaterials GmbH
US
Last updated May 27, 2026
What Botiss Biomaterials GmbH makes
Botiss Biomaterials GmbH produces dental bone matrix implants derived from animal sources, designed for bone regeneration in oral and maxillofacial procedures. Their portfolio also includes collagen-based dental regeneration membranes, intended to support tissue healing and integration in implant sites.
These devices are classified as Class II under regulatory frameworks, with authorisations granted through FDA 510(k) and UDI listings. The company is based in the US and operates within these regulatory pathways for its dental biomaterials.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Frequently asked questions
What types of medical devices does Botiss Biomaterials GmbH manufacture?
Botiss Biomaterials GmbH specializes in dental biomaterials, specifically animal-derived bone matrix implants and collagen-based dental regeneration membranes. These devices are primarily used in oral and maxillofacial procedures to support bone regeneration and tissue healing, such as during dental implant placements.
Where is Botiss Biomaterials GmbH based?
Botiss Biomaterials GmbH is based in the United States. The company’s operations and regulatory submissions are aligned with US-based frameworks, including FDA pathways for its dental biomaterials.
Which regulatory registries or databases list Botiss Biomaterials GmbH’s devices?
Botiss Biomaterials GmbH’s devices are listed in the FDA’s 510(k) premarket notification database and the FDA’s Unique Device Identifier (UDI) system. These registries reflect the regulatory authorisation process for its Class II dental biomaterials.
How are Botiss Biomaterials GmbH’s devices classified under regulatory frameworks?
Botiss Biomaterials GmbH’s devices are classified as Class II under regulatory frameworks. This classification applies to dental bone matrix implants and collagen membranes, which require premarket notification (510(k)) to demonstrate substantial equivalence to legally marketed predicate devices before commercial distribution.
AI-generated from registry data and not verified by a human reviewer.
Information
- Country
- US
- Address
- —
- Website
- botiss.com
- —
- —
- [email protected]
- Phone
- +49337698841985
- PRRC Contact
- —
- EUDAMED SRN
- —
- FDA FEI Number
- —
- DUNS Number
- 341685939
Catalogue (23)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| cerabone® | MEUS-1522 | FDA UDI | Class II | Active |
| Straumann® Jason® membrane | BS-683040 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1525 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1522 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1521 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1512 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1520 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1512 | FDA UDI | Class II | Active |
| Straumann® Jason® membrane | BS-682030 | FDA UDI | Class II | Active |
| Jason® membrane | MEUS-681520 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1525 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1520 | FDA UDI | Class II | Active |
| Jason® membrane | MEUS-682030 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1510 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1515 | FDA UDI | Class II | Active |
| Jason® membrane | MEUS-683040 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1510 | FDA UDI | Class II | Active |
| Straumann® Jason® membrane | BS-681520 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1511 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1521 | FDA UDI | Class II | Active |
| cerabone® | MEUS-1515 | FDA UDI | Class II | Active |
| Straumann® cerabone® | BS-1511 | FDA UDI | Class II | Active |
| Jason membrane | K242817 | FDA 510(k) | Class II | Active |
Related Companies
Authorised Representatives
No authorised representatives on record.
Importers
Not available yet.
Notified Bodies
Not available yet.
Authorities
Not available yet.
FDA Establishments (1)
Establishments registered with the FDA under this company group, matched by name.
- Botiss Biomaterials Gmbh Zossen Brandenburg · DE FEI 3014206569