OpenTex-TR

Primary DI

08800039001618

Basic UDI-DI Code

B-08800039001618

Reference

OpenTex-TR_P0210

Device Types

Single use Sterile

Regulation

Eu Mdd

Classification

Eu Md Class 2a

Status

On The Market

Manufacturer

Purgo Biologics Inc.

OpenTex-TR is composed of 100% polytetrafluoroethylene (PTFE) sheet and grade 1 titanium plate, which are biologically inert and tissue compatible. PTFE sheet of OpenTex-TR is designed to have a suitable surface structure and porosity to prevent integration and passage of bacteria within the interstices of the material, while maintaining space for host cells adhesion to the device. OpenTex-TR is designed to provide a favorable environment for neovascularization and healing of defects, through repopulating the bone derived cells and protecting the boney defects from migration of the gingival tissue derived cells. Since the adequate space-maintenance is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse, but also flexible enough to easily conform to tissue contours and reduce perforations of overlying soft tissue. OpenTex-TR is provided sterile by ethylene oxide and sterility is ensured by Tyvek pouch. Sterility of OpenTex-TR is valid 5 years after sterilization.

Other on-the-market devices with the same classification (Eu Md Class 2a) and regulation (EU MDD).