OrthoDots CLEAR from OrVance is now compliant for sales in the United States, Canada, the European Union, Australia, and 24 other countries. The company plans on launching the product this fall with select global and regional partners. It also is launching a free product plan for all orthodontic resident programs in North America.
“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, CEO of OrVance.
“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,” said Schutt.
“None of the generic dental wax currently dispensed to patients in our industry offer these features, which leaves our patients and industry vulnerable,” Schutt said.
“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 Dr. Mike Silver, 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,” said Silver.
According to OrVance, OrthoDots is extremely moldable, comfortable, and easy to apply, with 20 times the pliability of the leading dental wax. It is designed to stay on and protect longer than dental wax with proprietary moisture activated technology. There is no need to dry bracket to apply, and it is safe to use while eating and drinking.
“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,” said Schutt.