Dentsply Sirona Titanium Bases system

The Dentsply Sirona Titanium Bases system is a titanium alloy component that serves as the bottom half of a two-piece dental abutment for endosseous implants. It is bonded to a patient-specific CEREC Cercon 4D ceramic block (top half) and attached to dental implants with an abutment screw to support single cement-retained crowns in partially or fully edentulous patients.

The proposed TiBases are made of the same Ti6Al4V material and manufactured using identical processes as the predicate device K193408. Key differences include: introduction of 2 and 3 mm gingival heights (predicate had 1 and 2 mm); replacement of the inCoris Zi meso top-half material with CEREC Cercon 4D; and updated labeling to MR Conditional status. The design, post height, angulation range, and workflow remain substantially the same.

ISO 14801:2016 (dynamic loading test for endosseous dental implants); ASTM F2052-21 and F2213-17 (magnetic resonance induced displacement force and torque); ASTM F2119-07 (MR image artifacts); ISO 17665-1:2006 (sterilization validation); ISO 10993-1:2018 (biocompatibility); FDA Class II Special Controls Guidance for root-form endosseous dental implants and abutments.

The proposed device uses identical material and manufacturing as the predicate K193408 with the same general intended use for single cement-retained restorations. The new 3 mm gingival height falls within the range offered by reference devices TruBase K213961/K241485, supported by fatigue testing showing equivalent performance. The CEREC Cercon 4D top-half material was already cleared for use with predicate TiBases in K234018, and MR testing demonstrates safety for the conditional labeling change. Software verification confirms the TiBases are properly integrated into the same CAD/CAM systems, and reprocessing/biocompatibility data included by reference demonstrate no new safety concerns.