OrVance LLC, Grand Rapids, Mich, has published a new white paper looking at the quality, safety, and compliance of its proprietary OrthoDots® CLEAR dental wax against traditional dental wax products. The white paper, which was developed with several industry experts, evaluates commodity dental wax in the three aforementioned areas, concluding that traditional dental wax is no longer up to the standards of other consumer healthcare products.
According to Michael Silver, PhD, co-inventor of OrthoDots, “When we set out to develop a better solution than traditional dental wax, we knew that our product could occasionally be ingested and that it would come in contact with bodily fluids. This required us to carefully consider many quality and safety issues, including the ingredients we use, appropriate manufacturing standards, how the product should be packaged, appropriate labeling, and product traceability.”
“Additionally, when benchmarking how commodity dental wax is dispensed and used by patients relative to other healthcare products, our findings were shocking,” Silver said, in a press release from the company. “We simply could not find any similar consumer healthcare product that was not packaged in hygienic unit-of-use packaging, with no disclosure of ingredients, and without labeling or lot codes for traceability in the event of a potential quality or safety issue. And when talking with professionals in other healthcare sectors, they agreed that unlabeled dental wax in its current form is no longer appropriate for its intended use, especially when considering that it’s primarily used by children.”
Mart McClellan, DDS, MS, an orthodontist in Kenilworth, Ill, former president of the Illinois Society of Orthodontists, and advisor to OrVance, added, “When I learned about the significant advancements in quality and safety OrthoDots provide over the common dental wax, my advice to OrVance has been to place more emphasis on these important features in their communications to our profession. My staff and patients love OrthoDots as a more effective solution to improve patient comfort and satisfaction…. But it is also clear that my patients and their parents are increasingly concerned about hygiene and the safety of products used over the course of their treatment.”
In their white paper, the OrVance owners and expert advisors also address regulatory compliance related to quality and safety, particularly as it relates to U.S. and European Union regulations.