X-Guide® Is The First Dental Surgical Navigation System To Receive EU MDR Certification
LANSDALE, Pa., March 5, 2024 /PRNewswire/ -- X-Nav Technologies, LLC announced that the X-Guide® Dynamic 3D Surgical Navigation System is the first of its kind to receive certification under the European Union Medical Device Regulation 2017/745, commonly referred to as EU MDR.
- The regulation requires a thorough audit of a company's Technical Documentation, Clinical Evidence, and Quality Management System.
- The completion of this process certifies that the X-Guide System delivers the claimed clinical benefits for dental surgical procedures, including dental implant surgery and endodontic access.
- X-Guide is the industry-leading surgical navigation system used by dentists and clinicians around the world to deliver more accurate and less invasive dental surgical procedures with remarkable precision.
- The X-Guide Surgical Navigation System is available in 23 languages and 50+ countries, holds 31 trademarks and 50+ patents, and is used by over 50 universities around the world.