Custom Abutments AS

Medentika Custom Abutments AS are custom-designed dental abutments intended for use with dental implants to support single or multiple tooth prostheses in patients who are partially or fully edentulous. They are digitally designed using Straumann CARES software and manufactured at Straumann-validated milling centers. The abutments are compatible with multiple implant systems including Nobel Biocare, Dentsply, Straumann, ZimVie, and OSSTEM implant bodies.

The key distinguishing feature is an angulated screw channel (up to 25° from the implant axis) rather than a straight screw channel found in predicate devices. All other characteristics are equivalent: titanium alloy (Ti6Al4V conforming to ASTM F136) construction, cement-retained prosthesis attachment, comparable design limits (0.5 mm minimum wall thickness to screw channel), and identical series/implant compatibility to existing marketed Custom Abutments.

Dynamic fatigue testing per ISO 14801:2016, dimensional analysis and reverse engineering per FDA Class II special controls guidance, steam sterilization validation per ISO 17665-1 and ISO/TS 17665-2, MR safety testing per ASTM F2052-15, F2213-06, F2182-11a, and F2119-13, and biocompatibility per ISO 10993-1.

Substantial equivalence is based on identical intended use, materials, manufacturing process, and compatible implant systems compared to predicate K223113. The angulated screw channel design is supported by reference to previously cleared Medentika TiBases CAD/CAM ASC Flex (K223113 and K242542) which have the same feature. No new implant series, diameters, or platform diameters are introduced, and all performance testing demonstrates equivalent safety and effectiveness.