GBR System

The GBR System is a set of titanium screws and pins used to stabilize and fix bone grafts, bone filling materials, and barrier membranes during guided bone regeneration procedures in the oral cavity. The device provides block bone graft fixation, stabilizes graft particles by creating a tent effect under the membrane, and secures the membrane in place.

The subject device is manufactured from pure titanium Grade 4 (ASTM F67-13) in multiple diameters (1, 1.2, 1.5, 2 mm) and various lengths (3.7–14 mm). It is a single-use, non-sterile device that requires autoclave sterilization before use. The primary predicate (Straumann GBR System) uses the same titanium Grade 4 material in similar diameters and lengths, while reference devices use titanium alloy (Ti-6Al-4V) with different dimensional ranges.

The device was tested according to TS EN ISO 19023, ASTM F543-23 (insertion torque, fracture torque, pull-out tests), EN 1642, ISO 5832-2, EN 17665-1 (autoclave sterilization validation), and FDA guidance on MRI safety. Biocompatibility assessment leveraged data from a prior FDA-approved application (K231100) using identical materials and manufacturing processes.

The device is substantially equivalent because it shares the same intended use, design principle, sterilization method, and single-use disposable nature as the predicate and reference devices. Although material, diameter, and length dimensions differ slightly from some predicates, mechanical testing (insertion torque, fracture torque, and pull-out tests) demonstrated no significant performance differences. The subject device's titanium Grade 4 composition and manufacturing process are identical to those of the primary predicate (Straumann GBR System K011698), establishing direct material and functional equivalence.