3Shape Abutment Designer receives 510(k) clearance from FDA

Copenhagen, September 15, 2016 –The United States FDA has issued a 510(k) clearance for 3Shape Abutment Designer, a functionality within 3Shape Dental System CAD/CAM software.

The 510(k) clearance covers all implant cases being designed using 3Shape Dental System software. A 3Shape Abutment Designer and/or Implant Bridge and Bars license is needed to use the functionality.
“There has been considerable discussion within the U.S. dental lab industry regarding CAD/CAM in-house abutment design. We hope that the 510(K) issuance brings clarity to the conversation for 3Shape dental lab product users. Who, like 3Shape, have always considered patient safety most important,” says Flemming Thorup, president and CEO at 3Shape.

First stand-alone CAD/CAM software to be cleared
The FDA 510(k) clearance for 3Shape Abutment Designer is now unique in that it marks the first time a stand-alone CAD/CAM software receives clearance under the FDA’s new product code PNP – Abutment design software for dental laboratories.

Implant library providers also need 510(k) clearance
3Shape Abutment Designer is part of 3Shape’s larger eco-system of CAD/CAM dental design software. Implant libraries integrated with 3Shape software will need to apply individually to receive 510(k) clearance.

In the United States, 3Shape Abutment Designer can only be used with libraries with documented 510(k) clearance.