(83 days)
The Straumann GBR System is intended for use in stabilizing and fixating bone grafts, bone filling material, and/or barrier membranes used for regeneration of bone in the oral cavity. The GBR technique can make it possible for the placement of dental implants in previously unsuitable sites.
The Straumann GBR System is comprised of bone plates, meshes, screws, and accompanying instruments. The cranial plates are offered in 2, 4, and 6 hole options. Screws with diameters of 1.2 and 1.5mm are used to secure the cranial plates in place. The plates and screws are composed of commercially pure Grade 4 titanium meeting ASTM F67.
The 0.9 and 1.5 mesh are available in uniform mesh size and pattern, and alternating mesh size and patterns. Screws with diameters of 1.2 and 1.5mm are used to secure the mesh in place. The meshes are composed of commercially pure Grade 1 titanium meeting ASTM F67.
The Straumann GBR System also includes a fixation screw used to stabilize and adapt the membranes. There are two variations of supporting screws which prevent the membrane from collapsing into the defect site, and in conjunction with a head screw, provide membrane fixation and support. The screws are composed of stainless steel.
The provided text is a 510(k) summary for the Straumann GBR System, which includes regulatory information, device description, and an intended use statement. However, it does not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or any details typically found in a clinical study report.
Therefore, I cannot provide the requested table and study details. The document is primarily a regulatory submission for substantial equivalence to predicate devices, focusing on materials and intended use rather than detailed performance evaluations with specific metrics.
§ 872.4760 Bone plate.
(a)
Identification. A bone plate is a metal device intended to stabilize fractured bone structures in the oral cavity. The bone segments are attached to the plate with screws to prevent movement of the segments.(b)
Classification. Class II.