• January
  • 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 of regulatory adhering,...

    Biodenta North America

    January 6 at 11:17 am

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  • April 2011
  • CAD/CAM Technology And Ceramic2in1

    BIODENTA helps laboratories get involved in CAD/CAM with little investment. Upon completion of training at the Bethesda, MD central milling and design facility, you’re equipped with a Biodenta Scanner; a computer with the latest design software; and ongoing telephone, internet and remote support. It also offers Ceramic2in1, a low-fusing ceramic with enamel-like wear characteristics. A stable matching and firing coefficient of thermal expansion ensures trouble-free processing on titanium and zirconium materials.

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