What is the FDA now requiring of Dental Laboratories making custom abutments?

By | August 24th, 2017|Categories: Dental compliance, FDA Compliance requirement from dental labs, FDA requirements from Dental Laboratories making custom abutments, FDA requirements from dental labs|Tags: , , |

What is the FDA now requiring of Dental Laboratories making custom abutments? The topic can be confusing, we are going to break it out into a few parts [...]

Understanding FDA Regulatory Compliance for Dental Labs

By | August 17th, 2017|Categories: Dental compliance, FDA regulatory, News|Tags: , , , , |

“The FDA has now determined how to regulate the CAD/CAM Dental Laboratory; A quality Management system needs to be in place” What Does The FDA Require Of Companies Selling [...]

Under the Microscope

By | August 1st, 2017|Categories: News|

Under the Microscope FDA oversight increases as laboratories transition to CAD/CAM production Pam Johnson Increased FDA enforcement activity involving audits of dental laboratories and production centers that manufacture Class II medical devices using CAD/CAM technology [...]

What does evo820 do?

By | July 17th, 2017|Categories: News|

evo820 was founded specifically to provide dental laboratories a turnkey pathway to regulatory compliance through a practical and affordable implementation of a Quality Management System that is specifically designed for the CAD/CAM dental laboratory. […]

Fda activity update

By | July 17th, 2017|Categories: News|

Over the last several years there has been a lot of information and misinformation circulating around the industry on the FDA’s perspective of dental laboratories manufacturing of CAD/CAM-based customized implant abutments, including all-titanium, hybrid titanium [...]

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