GRAND RAPIDS, MICHIGAN – January 10, 2019 – OrVance LLC, a developer of proprietary orthodontic products, announced its first shipments of the new globally compliant OrthoDots® CLEAR. OrthoDots® CLEAR is now the world’s first globally compliant product used for irritation caused by orthodontic treatment. It 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. It is preferred over traditional dental wax because it performs better, is transparent and is the first orthodontic wax that meets the quality and safety standards for today’s healthcare products.
OrthoDots® CLEAR, with its recently acquired CE marking, 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 simple instructions-for-use in 33 languages.
OrVance 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 (MHRA) in a leading EU market.
More information on the performance, quality and compliance benefits of OrthoDots® CLEAR can be found in the white papers at orvance.com. Suppliers and retailers interested in carrying OrthoDots® can contact OrVance at firstname.lastname@example.org.