The 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 laboratory industry regarding CAD/CAM in-house abutment design. We hope that the 510(K) issuance brings clarity to the conversation for 3Shape dental laboratory product users, who, like 3Shape, have always considered patient safety most important,” says Flemming Thorup, president and CEO at 3Shape.
The FDA 510(k) clearance for 3Shape Abutment Designer marks the first time a standalone CAD/CAM software has received clearance under the FDA’s new product code PNP - Abutment design software for dental laboratories.
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 US, 3Shape Abutment Designer can only be used with libraries with documented 510(k) clearance.