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.
“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 #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% 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 Dr. Mike Silver, OrVance’s Director of R&D and Technical Affairs, “In the many lunch and learn sessions we’ve done with orthodontic resident programs, we’ve consistently asked if anyone could name any product in all of healthcare — other than generic dental wax — that had none of the following quality and safety features: disclosure of ingredients, unit-of-use hygienic packaging, tamper-evidence and product traceability. We’ve not heard of a single similar product that is dispensed by a doctor and used by a patient with none of these features. Omitting these standards for a healthcare product that is occasionally ingested leaves our patients and industry vulnerable. This is why we’re passionate to lead the industry in providing a product that meets these critical standards.”
Finally, the generic dental wax that is widely sold to orthodontic practices is not compliant with current and upcoming regulations, particularly in the EU. 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.
Schutt continued, “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.”
More information on the performance, quality and compliance benefits of the product can be found in our white papers. Suppliers and retailers that are interested in carrying OrthoDots® CLEAR can contact us here.
