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Used in the chemical and mechanical cleansing of the root canal preparation during endodontic therapy

Oxy Glide™ allows for cleansing action that facilitates easy removal of vital pulp tissue and necrotic pulp tissue from the root canal. It is designed to be used with endodontic irrigation with sodium hypochlorite solutions. Oxygen bubbling occurs through the release of oxygen from the urea peroxide. This action allows for the pulp tissue, dentinal shavings, and debris to float out.

The provided text describes a 510(k) summary for a medical device called "Oxy Glide™," a root canal cleanser and lubricant. However, it does not contain any information about acceptance criteria, device performance testing, studies proving acceptance, sample sizes, expert involvement, ground truth establishment, or any of the other specific details requested in the prompt.

The document primarily focuses on establishing substantial equivalence to a predicate device (RC-PREP, a pre-1976 device) based on similar intended use, physical properties (viscosity, appearance, color, odor), and active ingredients. It explicitly states that "the use of Oxy Glide™ does not require additional biocompatibility testing" due to these similarities and the product's nature.

Therefore, I cannot fulfill the request to describe the acceptance criteria and the study that proves the device meets them because this information is not present in the provided text.

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