CAD/CAM customized abutments are classified as Medical Devices Level 2 by the FDA. In order to mill CAD/CAM customized abutments, the facility must have 510(k) clearance from the FDA or it is ILLEGAL (with the exception of authorized milling centers using all systems and materials from Sirona).
Various Factors Affect Quality of CAD/CAM Custom Abutments
The evolution of automated technologies used in dental prosthetics now allows even the smallest of dental laboratories to manufacture CAD/CAM restorations that were once only feasible from major milling centers or corporations.
With so many milling machines and scanners hitting the market, laboratory owners may be tempted to get into the game. We at CreoDent would like to share our experience that machine salesmen or distributors likely will not tell you.
With almost 30 years of hands-on functional and cosmetic design experience, Creodent Milling Center provides restorations that require minimal adjustment. Our full-contour crown and zirconia copings are milled ready for porcelain or glaze.