Denterprise International has provided FDA 510(k) consulting services for more than 30 years, having cleared petitions ranging from radiation generators (portable, extraoral and pan/ceph/3D x-ray), orthopedic external fixators, and dental imaging products (intraoral cameras, digital sensors and imaging software), to long-established denture base resins and cutting-edge CAD/CAM 3D “additive printing” devices.
Clients love our hands-on touch. Denterprise International offers a dedicated staff to deliver what you need, and that is fast clearance of your medical device for sale in the U.S., Canada, or Europe.
So come meet the team…
Claude D. Berthoin
Claude Berthoin is Executive Chairman of The Denterprise Group, a diverse array of medical device importers and distributors that serve the dental industry globally.
A native of France who has made America his home for the past forty years, Claude first ventured into the FDA 510(k) Premarket Notification program in 1990, registering his own products. That exposure led to device manufacturers across Europe, Asia, and the Americas seeking help with the introduction of new medical and dental products into the U.S., Canada, and Europe.
Claude is married with two children. His hobbies center on family, work and travel, with a particular passion for exploring his native Europe each summer.
Jim Gibson is Chief Operating Officer of The Denterprise Group. A graduate of Georgia Tech and MBA at UNC Chapel Hill Jim has spent 30 years either consulting with or starting and operating marketing and manufacturing businesses. In college he took pre-med biology related courses as electives and provided environmental studies for an environmental engineering firm in the 70’s. That experience supported his ability to work with companies who were directly or indirectly associated with technical biological services or products.
Jim is married with three children who have given him 4 grandchildren with one daughter and husband who work as managers in a pharmaceutical consulting company.
W. Lee Strong
Lee is your first point of contact with 510K FDA Consulting. His background is working in information technology,dental x-ray, product management, and quality system certification. He answers your questions and emails and works with you all the way through to the final clearance of your device(s).
Karen is a proven leader in project management, organization management, and business processes for the Federal Government and the private enterprise. Her strong technical skills in operation research, cost and economic analysis, regulatory documents, combined with her leadership skills have been recognized with numerous awards and opportunities in the area of organization management and business processes.
Karen has joined the Denterprise Team as a 510(k) Consultant. Her Federal Government background will benefit both Denterprise and the Denterprise Clients.