exocad America and Biodenta Announce Path to Compliance
WOBURN, Mass-- Today, exocad America and the Biodenta Group announce that US dental labs have a new path to produce 510(K) cleared, in-house milled, custom dental abutments using the Biodenta implant library integrated into exocad DentalCAD software. In order to achieve this, labs must implement FDA compliant Good Manufacturing Processes (GMP's) into their organization, sign up as a sub-contract manufacturer with Biodenta, and complete an audit process. Then, dental labs can use Biodenta's milling blanks (the PreFAB-4 system), approved CAM software, and procedures to manufacture milled custom abutments in the US without the time and expense of submitting an FDA 510(k).
A number of exocad resellers will be supporting the Biodenta contract manufacturing solution for in-house milled custom abutments.
Larry Bodony, President of exocad America says "We are thrilled to have an innovator like Biodenta offering compliant custom abutment manufacturing process to the industry. We love to provide our customers a broad spectrum of production options, and Biodenta's process is an attractive choice for dental labs across the US who want to become both self-sufficient and compliant without the time and expense of filing their own 510(k)".
Biodenta Group's VP of Products & Solutions Strategy, Alireza Tavassoli said "We are pleased to be partnered with exocad and a number of their resellers to bring our vision of compliant manufacturing processes to the market. We look forward to working with open systems partners to disseminate this solution across the US".