mininavident AG today announced that the company has received the CE (Conformité Européenne) Mark approval for its DENACAM system. DENACAM is a miniaturized dynamic navigation system for dental implants which guides the physician in real-time and 3D to the correct positioning of the implant – all without the use of drill guides and comparable to freehand surgery.
The CE Mark approval was based on rigorous evaluation by SQS (Swiss Association for Quality and Management Systems) and demonstrated conformance to European harmonized standards in areas of health, safety and environmental protection and allows mininavident AG to launch the DENACAM system in the European market.
“I am proud of this significant milestone we reached with the team and the support of our key suppliers”, said Michael Breitenstein (COO). It is also further evidence of our commitment to meet the highest standards of quality and regulatory compliance as a medical device manufacturer.
“We have noticed growing demand for 3D navigation systems which can be easily integrated into dental practices or cranio-maxillofacial surgery clinics”, said Frank Berlinghoff (VP).
DENACAM is the world’s first CE Marked dynamic navigation system with miniaturized components for smart integration with surgical motors and intra-oral positioning of dual-mode-markers. There is also a patented automatic registration tool for dental drills and the intuitive navigation software has an open interface for compatibility with most implant planning software systems.
The launch will start in early summer 2018 with a limited market release in Switzerland, Germany, Austria and Czech Republic, driven by an attractive “early-bird-offer” and will then be followed by a full market release in cooperation with distribution channels from dental industry.
mininavident AG will apply for listing the DENACAM system as a Class IIa medical device with US FDA and Health Canada.
mininavident AG is a spin-out from University Hospital Basel and University of Applied Sciences Northwestern Switzerland. mininavident AG has won a number of prestigious awards and quality labels like the CTI Certified Label, TOP100 Startup Award, Quality Management System 13485, Swiss Technology Award 2015, and a Design Prize.