Dentists are asking everyday about using legal, FDA cleared custom abutments. Dental laboratories are concerned about the FDA potential overreach. evo820 was founded by dental industry professionals to provide laboratories a 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.
With the FDA now determining how to regulate CAD/CAM manufactured implant supported restorations, It is critical that the dental laboratory owner understand this determination requires milling centers or dental laboratories processing CAD/CAM abutments, either Titanium custom abutments or hybrid Titanium base custom abutments, must have a Quality Management System (QMS) in place and register with the FDA.
evo820, a company comprised of dental laboratory veterans, will provide you a customized QMS for your laboratory that is practical and affordable for any sized laboratory.