OrVance Announces First Shipments of Globally Compliant OrthoDots Clear

OrVance Announces First Shipments of Globally Compliant OrthoDots Clear
Posted: January 10, 2019
Edited by Orthotown staff

GRAND RAPIDS, Mich.—OrVance, a developer of proprietary orthodontic products, announced its first shipments of the new globally compliant OrthoDots Clear. The product, which is used for irritation caused by orthodontic treatment, is compliant for sales in the U.S., Canada, the European Union, Australia and 24 other countries.
 
The proprietary OrthoDots Clear technology consists of a moisture-activated adhesive layer on a clear medical-grade silicone. With its recently acquired CE marking, the product is compliant with current medical device regulations in the EU. The OrthoDots Clear 48-count ProPack, 12-count patient pack and 4-count sample pack have all been redesigned for global sales to orthodontic practices. The new product is supported by a multilingual webpage and includes a package insert with instructions-for-use in 33 languages.
 
“We’re excited about the acceptance of OrthoDots Clear as the new standard of care in orthodontics,” said Ron Schutt, OrVance’s CEO. “We’re already the No. 1 orthodontic wax used in orthodontic resident programs in North America. Since launching our educational initiative for these programs just six months ago, over 50 percent have made the conversion from traditional dental wax. Residents strongly prefer the performance of OrthoDots over traditional wax. But it’s equally important to note that residents have quickly embraced OrthoDots because they now understand generic wax does not provide the necessary quality and safety features demanded by today’s consumers.”
 
According to OrVance, the generic dental wax that is widely sold to orthodontic practices is not compliant with current and upcoming regulations, particularly in the EU. The company has received consistent interpretation on the noncompliance of generic dental wax from two global regulatory firms, an EU authorized representative and directly from the Medicines and Healthcare products Regulatory Agency in a leading EU market.
 
“We are proud to partner with world-class suppliers and retailers that want to provide a better-performing product with improved quality and safety features. We offer our partners a globally compliant product and a turnkey marketing program that makes the addition to their product line as simple as possible. 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," said Schutt.
 
For more information, visit orvance.com.

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