Nobel Biocare: Our Implant Restorations are Fully FDA Compliant

Nobel Biocare has always been and continues to be in full compliance with the FDA regulation and NADL recommendations when producing individualized implant prosthetics. The recent communication from NADL with an important FDA Alert regarding the use of CAD/CAM for in-lab milling of implant abutments does not affect any Nobel Biocare products. Our NobelProcera manufacturing facility in Mahwah, New Jersey is registered as a Medical Device Manufacturer. In addition we have FDA 510(k) clearance on all implants and abutments we currently offer for purchase.
 
We are committed to offering individualized implant prosthetics for a wide range of implant systems that are regulatory compliant and industry leading in quality. For labs that do not work exclusively with NobelProcera, we understand that this news may affect their existing workflows. If that’s the case, we’re here to help. As the pioneer in CAD/CAM dentistry we have over 30 years’ success in CAD/CAM restorations...