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Sign in to claim this brandSigmagraft, Inc.
United States·US-MF-000015980
Last updated September 17, 2026
What Sigmagraft, Inc. makes
Sigmagraft, Inc. manufactures dental bone matrix implants derived from animal sources, designed to support bone regeneration in oral and maxillofacial procedures. Their product line also includes collagen-based membranes for dental regeneration, intended to aid tissue integration and healing in periodontal and implant surgeries. These materials are used in procedures requiring controlled bone growth or soft tissue regeneration.
The company’s devices are classified as Class II and Class III under regulatory frameworks, with listings in the EU’s EUDAMED database, the FDA’s 510(k) premarket notification process, and the FDA’s Unique Device Identifier (UDI) system. Their portfolio is subject to compliance with both U.S. and European medical device regulations, ensuring adherence to stringent safety and performance standards.
Written from this company's registered devices by an AI model, and not verified by a human reviewer.
Information
- Country
- United States
- Address
- 575, Sally Place, Fullerton, United States
- Website
- sigmagraft.com/
- —
- —
- [email protected]
- Phone
- 7145250114
- PRRC Contact
- Elcin Chang
- EUDAMED SRN
- US-MF-000015980
- FDA FEI Number
- 3009598981
- DUNS Number
- 078893672
Catalogue (39)
| Device | Model / Reference | Registries | Class | Status |
|---|---|---|---|---|
| InterOss® | IOSG050 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-P450 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-100 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-1000-200 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-S-250-100 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-P150 | FDA UDI | Class II | Active |
| InterCollagen Guide | ICG2030 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-500 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-250 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-250-025 | FDA UDI | Class II | Active |
| Puraxen+ | XEN-S-1000-050 | FDA UDI | Class II | Active |
| InterCollagen Guide | ICG2525 | FDA UDI | Class II | Active |
| InterCollagen Guide | ICG3040 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-1000-050 | FDA UDI | Class II | Active |
| InterCollagen Guide | ICG1520 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-S-250-025 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-P250 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-S-250-050 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-350 | FDA UDI | Class II | Active |
| InterOss | IOSG015 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-050 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-250-200 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-250-050 | FDA UDI | Class II | Active |
| InterOss Collagen | IOC-P400 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-1000-100 | FDA UDI | Class II | Active |
| PuraXen+ | XEN-250-100 | FDA UDI | Class II | Active |
| InterOss Collagen | K221808 | FDA 510(k) | Class II | Active |
| InterCollagen® Guide | K223912 | FDA 510(k) | Class II | Active |
| InterOss® | IOLGS050 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOLG100 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSGS100 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSG500 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSGS025 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOLG050 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOLGS100 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSG100 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSG200 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOSG025 | EUDAMEDFDA UDI | Class III | Active |
| InterOss® | IOLGS150 | EUDAMEDFDA UDI | Class III | Active |
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