Biodenta North America Introduces FDA-Cleared Open System for Custom Abutments

Biodenta North America launched its DentaSwiss PreFAB-4 system, an open CAD/CAM system with a price point below $30,000. Using the system, that includes the DS1300 wet milling unit and 3Shape scanner and design software, laboratories can produce CAD/CAM custom abutments in compliance with FDA regulations provided they establish a quality management system fulfilling the QSR requirement; register with the FDA as a Biodenta (contract) manufacturer; and follow Biodenta’s device master record (DMR) and specifications for production, quality check and labeling.

The company has worked closely with FDA consultants for the past six years and attained FDA 510(k) premarket notification clearance on the final product—custom CAD/CAM titanium and hybrid abutments—rather than on a closed system. “By offering transparent and university-validated CAD/CAM products and solutions, we have become a key dental laboratory industry partner who will support labs in achieving...