THE Graft Collagen
Basic Information
- Primary DI
- 08800039005067
- Basic UDI-DI Code
- B-08800039005067
- Reference
- TCR-02
- Device Types
-
Single use Sterile
- Regulation
- Eu Mdd
- Classification
- Eu Md Class 3
- Status
- On The Market
- Manufacturer
- Purgo Biologics Inc.
Additional Description
THE Graft Collagen, a form of block and ring composed of porcine derived bone mineral matrix from cancellous bone and Type I Collagen from porcine tendon, is a material used to fill, augment, and/or reconstruct periodontal, oral, and maxillofacial defects. The bone mineral matrix is similar to physical and chemical aspects of mineralized matrix of human bone. Hydrated collagen components have viscosity that facilitates for blending bone mineral matrix. With this characterization, it can be trimmed and/or molded to the various shapes of defects and can be attached in bone defect site. THE Graft Collagen is sterilized using gamma irradiation. As time passes, THE Graft Collagen is partially transformed by the osteoclast and osteoblast.
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q010302 | DENTAL GRAFT DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II Section 4 | 1434-MDD-171/2021 | POLSKIE CENTRUM BADAN I CERTYFIKACJI S.A. | Expired |
Available In Countries
Similar Devices
Other on-the-market devices with the same classification (Eu Md Class 3) and regulation (EU MDD).