3Shape Abutment Designer, a functionality within 3Shape Dental System CAD/CAM software, recently received 510(k) clearance from the FDA.
The clearance covers all implant cases being designed using 3Shape Dental System software, according to a press release. A 3Shape Abutment Designer and/or Implant Bridge and Bars license is required to use the functionality.
This marks the first time a stand-alone 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 the company’s CAD/CAM dental design software. Implant libraries integrated with 3Shape software must apply individually to receive 510(k) clearance. In the U.S., 3Shape Abutment Designer can only be used with libraries with documented 510(k) clearance.
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