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OpenTex is a temporarily implantable material (non-resorbable) for as a space-making barrier in the treatment of periodontal defects.

OpenTex is a non-resorbable PTFE membrane composed of proprietary 100% polytetrafluoroethylene (PTFE) sheet with inert biological features and predictable barrier effect. OpenTex is designed to function as a physical barrier to avoid gingival cell invasion, thus providing a favorable environment for neovascularization and bone derived cells to repopulate and repair the defect. Since space-making is critical to this procedure, the membrane is sufficiently stiff to prevent spontaneous collapse but supple enough to conform easily to tissue contours. OpenTex is supplied sterile and intended for single use only. It is available in various sizes.

This is a 510(k) summary for a medical device called OpenTex, a non-resorbable PTFE membrane for guided tissue regeneration in periodontal defects. The information provided is for regulatory clearance and does not involve AI or algorithms with human-in-the-loop performance. Therefore, many of the requested fields are not applicable.

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1. Table of Acceptance Criteria and Reported Device Performance

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