Biodenta: Our Custom Abutment System is Regulatory-Compliant

For past six years, Biodenta has worked thoroughly with FDA consultants to offer dental laboratories regulatory compliant ways to manufacture CAD/CAM custom abutments in-house. Rather than clearing a closed system, we have attained FDA 510(k) premarket notification clearance for intent to market final product: custom CAD/CAM titanium and hybrid abutments. Laboratories will be able to produce CAD/CAM custom abutments in compliance with FDA regulations by using Biodenta’s DentaSwiss PreFAB-4 system, after establishing a quality management system fulfilling the QSR requirements, registering as a Biodenta (contract) manufacturer at FDA data base, following Biodenta’s device master record (DMR) and specifications for production, quality check, and labeling. “By offering transparent and university validated CAD/CAM products and solutions, we have become the key dental laboratory industry partner who will support them in achieving their long term goal...