OrVance - OrthoDots® CLEAR: Innovative and Compliant Alternative to Dental Wax
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Ron Schutt, CEO & Business Development
A source of wider smiles among patients and oral care practices is OrVance LLC, a developer of proprietary orthodontic products committed to delivering world-class innovation in orthodontics and dentistry. The company’s flagship product focuses on providing a radical alternative to generic dental wax. Being the only broadly available product in the market dispensed by orthodontists for abrasions caused from orthodontic treatment, generic dental wax has stayed in the market without innovation for more than five decades. “Moreover, aside from being obsolete in performance and aesthetics, we believe generic dental wax has become more of a liability to the orthodontic profession since it lacks universally accepted quality and safety features that have been in place for more than 25 years,” says Ron Schutt, the CEO of OrVance LLC. The common unlabeled dental wax is also noncompliant with current and upcoming regulations in the EU. On the other hand, OrVance’s flagship product, OrthoDots CLEAR delivers on all the essential quality and regulatory requirements that generic dental wax does not—hygienic unit-of-use packaging, tamper-evident packaging, proper labeling for product traceability, and disclosure of ingredients. In terms of regulatory compliance, OrthoDots is the world’s first globally compliant orthodontic wax that is fully compliant for sales in the U.S., the European Union, and 26 other countries.
Traditional dental wax requires the patient to tear off a pea-sized piece of “wax” from a bulk piece, which is not hygienic or appropriate for in-office application. The wax being opaque appears unattractive. Without adhesive, traditional wax typically crumbles and is occasionally swallowed and ingested. This necessitates quality and safety controls in terms of the ingredients used along with appropriate manufacturing, packaging, and labeling. In contrast, patients and orthodontists can safely and conveniently use OrthoDots with their hygienic single-use packaging.
The product’s package insert conveys universally comprehensible instructions for use, and their website displays product information in 33 different languages including all languages across the EU. OrthoDots are manufactured in the U.S. sourcing all materials from within the country to best control quality. The product’s two ingredients— medical grade silicone and polyvinylpyrrolidone (PVP) are made in the U.S. following Current Good Manufacturing Practices (CGMPs) ensuring a strong safety profile. However, generic dental wax is made by many different manufacturers and most of the U.S. retail brands are made in China. Furthermore, with its moisture-activated adhesive, OrthoDots sticks to orthodontic appliances including clear aligner trays for a prolonged duration and is non-toxic and latex-free. OrthoDots exhibits superior performance being 30x more tear-resistant, 17x more transparent and 20x more pliable than dental wax.
According to the preliminary results of OrVance’s recent survey of U.S. orthodontic residents regarding products used for the treatment of pain and irritation caused by orthodontic appliances, 100 percent residents agree that “mitigation of pain from irritation is an important part of orthodontic treatment.” Majority of the residents are against using generic dental wax without the required safety and quality features. Illustrating OrVance’s noteworthy impact on orthodontics, over 80 percent of the residents express appreciation for the features of OrthoDots and intend to incorporate it into their practice.
In terms of competition, “OrVance is working with and not against leading suppliers and stakeholders in the orthodontic industry,” states Schutt. The company is partnering with leading suppliers globally to immediately bring them into compliance with current healthcare standards and regulations. OrVance is simultaneously encouraging practices to promptly stop dispensing commodity dental wax to their patients and return it to their suppliers. “With our partners, our goal is to replace all noncompliant wax in the orthodontic industry by early 2020 before the new MDR goes into effect.”
OrVance is also turning their attention towards the U.S. brick and mortar retail channel for growth. “We also want to leverage OrthoDots and following products to enhance the orthodontic profession in the eyes of the consumer,” concludes Schutt.
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