Our Services  Preparation and submission of 510(k) Premarket Notification for your new or modified medical device. 510(k)  Fixed pricing at affordable rates—savings passed on from our specialty focus on medical device regulatory clearance.  Liaison between your company and FDA that responds to questions and FDA concerns.  All regulatory responsibilities and interests of our clients are handled professionally, confidentially and promptly.  Listing of your medical device.  Establishment Registration for your firm.  Small Business registration (to receive discount on 510(k) fee).  Acting as U.S. Agent (foreign manufacturers).  Import guidance.  Accession Number advice to import radiation-emitting devices.  New FDA Universal Device Identifier (UDI) guidelines. Call for Free Consultation 800-323-2690 X-315 FDA 510(k) Medical Device Clearance for USA Denterprise International, Inc. A Florida-based leader in both dental imaging technology and FDA regulatory consulting since 1996, Denterprise is a focused provider of FDA clearance expertise for medical device manufacturers, importers, and relabelers. Founder Claude D. Berthoin and CRO John F. Gillespy are pleased to have successfully represented numerous medical device clients from Europe, Korea, Japan, Brazil, Mexico, and of course the U.S. and Canada. John F. Gillespy Chief Regulatory Officer Denterprise International, Inc. 110 E. Granada Blvd., Suite 207 Ormond Beach, FL 32176 800-323-2690 X-315 386-453-1214 (Cell) [email protected] FDA Medical Device Regulatory Consultants at Denterprise International, Inc. Experts at clearing new and modified medical devices through the FDA 510(k) pathway. Get your products approved quicker, more efficiently, and with greater chance of success. Clients spanning the globe— from West (U.S. and Europe) to East (Korea and Japan). Are You FDA Compliant? All Medical and Dental devices intended for human use are closely regulated by the FDA. In short, you cannot legally market such products in the U.S. without proper registration, listing, and clearance or approval from the Agency. John F. Gillespy, MBA Mr. Gillespy earned a B.A. in Economics from Duke University and a B.B.A. in Accounting from Stetson University. He went on to receive an MBA from Duke’s Fuqua School of Business, where he was a Fuqua Scholar (top 10% of his class). After career stops as a CPA, investment banker and real estate entrepreneur, Mr. Gillespy entered the medical device field as CFO of Denterprise International, Inc. Today he specializes in medical device 510(k)s as head of the company’s regulatory division. We specialize in helping small and medium-size firms through that regulatory process, whether to bring a competitive “me, too” device to market, or to clear modifications to the technology or intended use of an existing product. In fact, nothing pleases us more than forwarding that “okay” letter from FDA to another satisfied customer. List of Recent FDA Regulatory Clients LIAC 10 MeV Tumor Zapper (Italy) Cauterrnax Surgical Pen (Brazil) BZD Zirconia Blocks (Italy) Crown Remover Instrument (USA) Z-Ray Sensor (USA) Z70 Extraoral X-Ray (USA) Hyperion X9 CBCT (Italy) Dr.Cam Intraoral Camera (Japan) I-Max Touch 3D X-Ray (France) Orthopaedic Femoral Nail (Italy) DX3000 Handheld X-Ray (Korea) Pan/Ceph X-Ray (China) NewTom VGi & 5G CBCT (Italy) Aladdin Opthalmic Viewer (Italy) External Fixator System (Italy) Wound Therapy Treatment (USA) Visiofocus Infrared Thermometer Why Choose Us? Clients from across the globe choose our relatively small firm because we offer great service and even better value. Rather than spreading ourselves too thin, we are laser-focused on clearing your device through the federal bureaucracy. That means following the FDA 510(k) petition pathway, which generally takes 4 to 6 months. You needn’t pay 2 to 3 times as much to someone else! Dental Acrylic Resins (Japan) Anthos R7 Chair System (Italy) Zanza-Click Electrostimulator Fundus Opthalmic Camera (Italy) Opteo Intraoral Sensor (France) QuickRay Dental Sensor (USA) Opera Swing X-Ray Tables (Italy) CAD/CAM 3D Denture Printer (USA) BI Image Radiographic (Mexico)