THE Graft
Basic Information
- Primary DI
- 08800039000161
- Basic UDI-DI Code
- B-08800039000161
- Reference
- BG-B25
- 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 is a natural and porous bone mineral matrix consisted of HA [Hydroxyapatite]. It is manufactured by removal of all organic components from porcine bone. Due to its natural structure the anorganic bone mineral of THE Graft likens physical and chemical aspects of mineralized matrix of human bone. When packed into a bone defect, THE Graft gradually resorbs and is replaced with bone during the healing process. It is available in cancellous granules packaged in vial and syringe. THE Graft is provided sterile by gamma irradiation and sterility of THE Graft is valid 5 years after sterilization, but expected lifetime is depends on dental implant. [EN]
CND Nomenclature Codes
| Code | Description |
|---|---|
| Q010302 | DENTAL GRAFT DEVICES |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| MDD Annex II (excluding section 4) | 1434-MDD-200/2021 | 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).