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FDA’s Position on Milling Customized Implant Abutments

08-Jan-2016 The latest news around the dental industry is regarding FDA’s position on the in-house milling of customized implant abutments. According to information available to SafeLink Consulting, dental laboratories cannot machine mill customized implant abutments in the lab unless they own the 510(k) for the abutments or are using a system that has been cleared for manufacturing in the lab, such as Sirona’s InLab System.
 
FDA also states that there are no approved blanks for machine milling that are cleared for use in the dental lab. Labs may design the abutment using the design library of the 510(k) holder and sending the file to that company for manufacturing. Part of the Quality System requirements for dental laboratories is to ensure that all materials and component parts, including abutments and design software, have met the appropriate FDA requirements or the laboratory could be subject to FDA compliance enforcement.

Contact SafeLink Consulting for more information or for assistance.

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