Dental News - OrVance to enter European and other leading markets with OrthoDots CLEAR

Dental Tribune International

Fri. 8. February 2019

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GRAND RAPIDS, Mich., USA: OrVance, a developer of high quality orthodontic products, has announced the first shipment of its new, globally compliant orthodontic wax that will be available for sale in the European Union, the U.S. and 26 other countries. The wax is to be used for irritation caused by orthodontic treatment.

The OrthoDots CLEAR technology consists of a moisture-activated adhesive layer on clear medical-grade silicone. With its recently acquired CE marking, this orthodontic wax is now offered in different types of redesigned retail packs, is supported by a multilingual website and includes a package insert with directions for use in 33 languages.

“We’re excited about the acceptance of OrthoDots CLEAR as the new standard of care in orthodontics,” said OrVance CEO Ron Schutt. “We’re already the number one orthodontic wax used in orthodontic resident programs in North America. Since launching our educational initiative for these programs just six months ago, over 50 per cent have made the conversion from traditional dental wax”. Schutt added that residents much prefer OrthoDots over other wax, since they now understand that generic wax does not provide the necessary quality and safety features demanded by today’s consumers.

According to Dr. Michael Silver, OrVance’s director of R&D and technical affairs, the company has consistently asked its customers if they could name any product in healthcare—other than generic dental wax—that did not have such quality and safety features as disclosure of ingredients, unit-of-use hygienic packaging, tamper-evidence and product traceability. Silver cautions that these features should not be omitted as they establish quality standards for healthcare products. “This is why we’re passionate to lead the industry in providing a product that meets these critical standards,” he explained.

According to OrVance, the generic dental wax that is sold to orthodontic practices does not comply to current and upcoming regulations, particularly in the EU. OrVance has been consistently seeking advice on the noncompliance of generic orthodontic wax from two global regulatory firms, a European Authorized Representative and the Medicines and Healthcare products Regulatory Agency. “Given the compliance issues with generic wax, particularly in the EU, we will be expanding our focus on penetrating Europe and other leading markets with strategic distribution partners,” Schutt noted.

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