At the annual Graduate Orthodontic Residents Program (GORP) conference, OrVance LLC announced that OrthoDots Clear orthodontic wax is now compliant for global sales. The company said OrthoDots Clear will launch this fall with select global and regional partners and is compliant for sales in the US, Canada, the European Union, Australia, and 24 other countries.
"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," said Ron Schutt, OrVance’s CEO. "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 health-care products. None of the generic dental wax currently dispensed to patients in our industry [offers] these features, which leaves our patients and industry vulnerable."
"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," said Mike Silver, PhD, OrVance’s director of R & D and technical affairs. "We have received a consistent interpretation of this noncompliance from two global regulatory firms, local authorized representatives, and even a regulatory authority in one of the leading orthodontic markets in the EU."
"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," said Schutt. "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 [bringing] orthodontic wax into compliance with the quality requirements of today’s health-care products. The response from the resident programs has been extremely positive, and we enjoy their partnership."
For more information about OrthoDots Clear, visit orvance.com.
