WASHINGTON, Sept. 20, 2017 /PRNewswire/ — The United States International Trade Commission announced in a press release that it has voted to institute an investigation of certain periodontal laser devices and components thereof. The investigation follows Millennium Dental Technologies Inc.’s (MDT) complaint filed last month in which MDT alleged unfair competition from Fotona, LLC and Fotona d.o.o. (Fotona) by advertising periodontal tissue regeneration, a claim requiring clearance from the United States Food and Drug Administration (FDA). At present, MDT is the only company to be awarded FDA clearance for True Periodontal Regeneration.
The complaint alleges violations of section 337 of the Tariff Act of 1930 in the importation into the United States and sale of certain periodontal laser devices and components thereof by reason of false advertising. The complainant requests that the ITC issue a limited exclusion order and cease and desist orders in an effort to bar counterfeit and misbranded devices and products that hurt American jobs, hurt the American economy, and funnel money to off-shore banks.
“We are pleased that the USITC has officially opened an investigation into this matter,” states Robert H. Gregg II, DDS, Co-founder and President of Millennium Dental Technologies. “It has always been MDT’s mission to put the patients’ needs first. The FDA’s award for the clearance of True Regeneration is the result of many years and many millions of dollars to bring true periodontal regeneration to the dental profession for the benefit of patients and the public. Advertising and marketing a copy-cat procedure without regulatory clearance only serves to confuse and ultimately harm the public.”
“Not only does this confusion adversely impact American manufacturing jobs and the American economy, it places patients in harm’s way from inferior and misbranded dental devices and procedures,” comments Dawn M. Gregg, DDS, Vice President of Operations of MDT and Training Director for the Institute of Advanced Laser Dentistry (IALD). “It is vital that clinicians who are looking to integrate laser dentistry into their treatment services know the truth, which is that the LANAP protocol using the PerioLase MVP-7 is the only procedure scientifically proven to have regenerative results.”
ABOUT MILLENNIUM DENTAL TECHNOLOGIES, INC.: Headquartered in Cerritos, Calif., Millennium Dental Technologies, Inc., is the developer of the LANAP protocol for the treatment of gum disease and the manufacturer of the PerioLase MVP-7 digital dental laser. By providing a simple and comfortable experience with unique bone-building clinical results, MDT’s FDA-cleared LANAP protocol removes the fear from gum disease treatment, offering a less painful and less invasive regenerative treatment alternative to conventional surgery. The company’s founding clinician, Robert H. Gregg, II, continues to operate the company with the vision: To create better clinical outcomes in periodontal disease patients—and to remain true to the guiding principle—”It’s all about the patient.”