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The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.

The Guided Bone Regeneration (GBR) System is used to stabilize and fix bone filling materials and/or barrier membranes used for bone regeneration in the oral cavity.
MATERIALS: Only materials approved for medical purposes are used in the manufacture of products: Pure Titanium Grade 4 according to standard ISO 5832-2 and ASTM F67-13.

I am sorry, but the provided text is a 510(k) K233419 FDA clearance letter and related summary for a dental device called "GBR System". This document focuses on demonstrating substantial equivalence to existing predicate devices, primarily through non-clinical testing and comparison of technological characteristics.

It does not contain information about acceptance criteria for a study proving device performance, nor details about a study that would meet such criteria. Therefore, I cannot extract the requested information from this document.

The document discusses:

• Non-clinical tests: Biocompatibility, Insertion Torque, Fracture Torque, Pull-out tests, sterilization validation, and MRI compatibility. These are primarily engineering and material characterization tests, not clinical studies with acceptance criteria for device performance in patients.
• Comparison to predicate devices: This is done to establish substantial equivalence, not to prove that the device meets specific performance acceptance criteria from a clinical study.

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