Implant Practice US provides continuing education and other valuable resources to help you build upon your expertise in implantology. Our continuing education is updated regularly and accessible any time, from anywhere.
Become a subscriber today!

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

3Shape_Abutment
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.

Stay Relevant With Implant Practice US

Join our email list for CE courses and webinars, articles and mores

SUBSCRIBE TODAY

Implant Practice US is a leading dental journal and publication for dental implantology continuing education, oral implantology case studies, and more. Subscribe to Implant Practice US today!

ONLINE DENTAL CE

Earn dental continuing education credits as an Implant Practice US subscriber. Log in for online dental CE credits now!

Other Dental Publications

AGD PACE MedMark White

SUBSCRIBE TODAY

Implant Practice US is a leading dental journal and publication for dental implantology continuing education, oral implantology case studies, and more. Subscribe to Implant Practice US today!

ONLINE DENTAL CE

Earn dental continuing education credits as an Implant Practice US subscriber. Log in for online dental CE credits now!

Other Dental Publications

Copyright © 2024 Orthodontic Practice US - Dental Journal and Online Dental CE | MedMark LLC
15720 North Greenway Hayden Loop, Suite #9 Scottsdale, AZ 85260 | All rights Reserved | Privacy Policy | Terms & Conditions

Shopping Cart
Scroll to Top