Dental Device Expertise

MDCI works with dental device manufacturers to meet clinical, compliance and regulatory requirements to bring the product to market, including:

  • Curing lamps - software documentation review, performance testing program support, 510(k) premarket notification preparation
  • Ultrasonic dental devices - software documentation review, performance testing program support, 510(k) premarket notification preparation
  • Dental handpieces - developing reuse validation testing programs, 510(k) premarket notification preparation
  • Endosseous implants – clinical trial design, monitoring and data management activities to support FDA requirements
  • Dental scalers
  • Dental X-ray devices
  • Computerized dental restoration design system
  • Dental bone void fillers
  • Dental operative units
  • Dental airbrush devices

Dental Device Case Study

A European manufacturer with a broad array of dental devices including dental operative units, ultrasonic scalers, curing lamps, airbrushes, and dental handpieces, manufactures many devices that incorporate cutting-edge technological advancements. Some examples are power advancements of an ultrasonic generator, light source and power delivered by curing lamp, increased sophistication of electronic control systems to improve the ease of use of already marketed devices, and expansion of indications for use to include new dental procedures. This company has a long-standing relationship with MDCI and has turned to us for assistance with the assembly of the appropriate software documentation and development of performance testing to support multiple 510(k) premarket notifications, for both new devices and device modifications. MDCI worked with the client to overcome the significant challenge of developing the appropriate testing to validate the cleaning and disinfection of those devices with reusable components that directly contact the patient, i.e. dental handpieces, and devices containing waterlines.

Contact us today to learn more about our dental device expertise.

Contact Us

Reach our Massachusetts office at 1-508-643-0434, Monday through Friday, 9:00 a.m. to 5:00 p.m. Eastern. Or fill out our contact form and a consultant will contact you directly.

Useful Links

For all areas of expertise, MDCI offers the following services:

Client Testimonial

The expertise and knowledge that MDCI shared truly helps us accomplish our mission of helping U.S. companies increase their export sales.

- International Trade Specialist at US Department of Commerce