MAXmin Prophy Paste contains patented NuFluor. What is NuFluor?

MAXmin Prophylaxis Paste is a proprietary patented formula developed by Preventch R&D. Unlike other prophylaxis paste brands that simply added a compound designed for use in consumer product applications into their paste formulations, our R&D started from scratch reviewing a comprehensive list of paste ingredients, ingredient/ formulation interactions, the manufacturing process and… the result is MAXmin Prophylaxis Paste […]

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If these added derivative prophylaxis pastes haven’t been clinically proven, then why are so many end users interested in Calcium and Phosphate containing products?

Teeth need calcium, phosphate and fluoride. Fluoride ions bond easily with calcium ions always present on tooth surfaces and in saliva. Saliva is the mouth’s primary defense against tooth decay. Research has proven that fluoride works to prevent tooth decay by boosting the ability of saliva to return lost minerals to tooth enamel before cavities […]

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If prophy paste is not an effective “remin” product, what type of product(s) would be effective?

Prescription strength fluoride containing products (5,000 ppm or greater ) used on a more frequent basis have been shown to remineralize tooth surfaces. Short term remineralization is achieved via a product regime which includes twice daily use of a fluoride containing toothpaste and fluoride containing oral rinses supplemented by in-office treatment with fluoride containing gels, […]

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What are the regulatory requirement for dental prophylaxis products to be able to make therapeutic claims?

While the addition of anti-caries agents makes logical sense in dental prophylaxis, large scale, multi-center clinical studies are required to determine the safety and efficacy of prophylaxis paste containing these therapeutic additives. Clinical studies are expensive and in small professional markets, the payback from such studies would be cost prohibitive. Additionally, the wide spread use […]

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What product claims are allowable under this regulatory classification?

Dental prophylaxis pastes are indicated for cleaning and polishing teeth as part of a professionally administered prophylaxis treatment as described in the classification regulation for “oral cavity abrasive polishing agents” in the Code of Federal Regulations 21 CFR 872.6030. Identification. An oral cavity abrasive polishing agent is a device in paste or powder form that […]

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How are dental prophylaxis pastes regulated and classified in the USA?

Dental prophylaxis pastes are regulated by the FDA Center for Devices and Radiological Health (CDRH) and are classified as Class I Medical Devices.

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