Ann Arbor, Michigan – OrVance LLC announced at the annual Graduate Orthodontic Residents Program (GORP) conference that OrthoDots® CLEAR is now compliant for sales globally. The company said OrthoDots CLEAR will launch this fall with select global and regional partners and is compliant for sales in the U.S., Canada, the European Union, Australia and 24 other countries.
According to Ron Schutt, OrVance’s CEO, “We prioritized our global compliance program for OrthoDots CLEAR because generic dental wax no longer complies with the quality and regulatory requirements in many leading orthodontic markets. Since launching OrthoDots, we have consistently advocated that the ortho wax we dispense to patients should offer basic quality features such as hygienic single-use packaging, product traceability and tamper evidence—as with all similar healthcare products. None of the generic dental wax currently dispensed to patients in our industry offer these features, which leaves our patients and industry vulnerable.”
According to Dr. Mike Silver, OrVance’s Director of R&D and Technical Affairs, “The commodity dental wax in the market today does not comply with medical device regulations in many major orthodontic markets, including the EU and Australia. We have received a consistent interpretation of this non-compliance from two global regulatory firms, local authorized representatives and even a regulatory authority in one of the leading orthodontic markets in the EU.”
“OrthoDots CLEAR not only provides practices and patients the best solution, but we also now have a technical dossier, CE Marking and product specifications that we believe makes it the most globally compliant orthodontic wax across the leading orthodontic markets in the world.”
Schutt continued, “We chose to make this announcement at the GORP conference because resident programs are quickly embracing OrthoDots CLEAR as the replacement for traditional dental wax. As announced in June, we are funding a Free Product Plan to all Orthodontic Resident Programs in North America that are committed to improving the patient experience and to bring orthodontic wax into compliance with the quality requirements of today’s healthcare products. The response from the resident programs has been extremely positive and we enjoy their partnership.”