US International Trade Association Complaint filed by Millennium Dental Technologies, Inc. against Fotona, LLC and Fotona, d.o.o.
WASHINGTON, Aug. 31, 2017 /PRNewswire/ -- Millennium Dental Technologies, Inc. (MDT) announced that it has filed a complaint against Fotona, LLC and Fotona d.o.o. (Fotona) with the U.S. International Trade Commission alleging unfair competition by advertising periodontal tissue regeneration, a claim requiring clearances from the Food and Drug Administration (FDA). Fotona does not have FDA clearance for periodontal tissue regeneration.
False advertising and false claims of the clinical outcome of periodontal tissue regeneration by Fotona constitute an important patient and public safety issue.
This is the third time in three years that MDT has found it necessary to file a lawsuit against Fotona for business interference; now within an international platform.
Mark Monaghan, CEO of Millennium Dental Technologies states, "As a result of millions of dollars of exhaustive research, the FDA granted the PerioLase® MVP-7™ clearance for True Periodontal Regeneration - when used specifically in the LANAP® protocol. Both the LANAP protocol and the PerioLase MVP-7 dental laser are exclusive properties of Millennium Dental Technologies, Inc."
Co-founder and President of Millennium Dental Technologies, Robert H. Gregg II, DDS adds, "Millennium was founded on the core principle 'It's All About the Patient.' When other entities deliberately mislead the public about clinical efficacy, the ultimate losers are the patients who do not receive treatment to the standard of care. MDT must continue to do what is right for patients and call out Fotona's bad acts; this is why we have asked the ITC to investigate."
"When rival laser companies and their sales representatives provide false and misleading statements of efficacy or comparisons to the LANAP protocol that are not based in research or science – and clinicians believe these statements – the results include confusion in the marketplace leading to deceived doctors and patient injuries," commented Dawn M. Gregg, DDS, Vice President of Operations of Millennium Dental Technologies and Training Director for the Institute of Advanced Laser Dentistry (IALD).
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 vastly less painful and less invasive regenerative treatment alternative to conventional surgery. Its PerioLase® MVP-7™ is a 6-watt free-running variable-pulsed Nd:YAG dental laser featuring 7 pulse durations giving it the power and versatility to perform a wide range of soft- and hard-tissue laser procedures. The PerioLase® MVP-7™ is also developed for the LAPIP™ protocol, for the treatment of ailing dental implants. 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."
SOURCE Millennium Dental Technologies, Inc.
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