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Vella® 5% Sodium Fluoride Varnish with NuFluor® and Xylitol® is a topical fluoride varnish for the treatment of dentin hypersensitivity.

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The provided text is a 510(k) premarket notification letter from the FDA regarding a dental device called "Vella 5% Sodium Fluoride Varnish with NuFluor® and Xylitol®." This document primarily grants clearance for the device based on substantial equivalence to predicate devices and outlines regulatory requirements.

Crucially, the document does NOT contain information about acceptance criteria, device performance studies, sample sizes, data provenance, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, or standalone algorithm performance.

The letter focuses on regulatory approval based on equivalent indications for use, stating: "We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976..."

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. The document does not contain this type of clinical or performance study information.

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