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The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface areas of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed.

The Proxivent Kit is a fluoride containing varnish system intended for use as a desensitizing agent on the surface area of hypersensitive or potentially sensitive teeth where dentin or cementum is directly or indirectly exposed. The Proxivent Kit comprises two components, Proxivent Varnish and Proxivent Matrix Pads. The varnish component is intended for application on easily accessible sites such as the buccal and lingual surfaces. The matrix pads include three shapes; round discs; an anatomically H-shaped conformation and an elongated H-shaped conformation (HL). The pads are made of varnishes containing cross-linked gelatin that obdurate dental tubules and release fluoride to strategically targeted tooth surfaces for optimal effects at the microscopic and molecular level at sites not easily accessed. Proxivent matrix pads are small, comfortable devices that denta." professionals can position, for example, between the teeth or at a furcation where there is, or could be, sensitivity. Proxivent matrix pads are engineered to expand gently and lock into place, soften and protect exposed dentin and exude non-toxic micro-doses of fluoride onto and into the tooth crystals (e.g., of the cemetum and dentir ) at inaccessible regions, for example, furcations and between the teeth. The matrix pads biodegrade following their fluoride release.

The provided text describes a medical device, the Proxivent Kit, and its 510(k) premarket notification to the FDA. However, it does not contain any information regarding specific acceptance criteria, study performance data, sample sizes, expert qualifications, adjudication methods, or ground truth establishment relevant to the performance metrics of the device.

The document states that the Proxivent Kit is substantially equivalent to predicate devices Duraflor® dental cavity varnish and Duraphat® dental cavity varnish (subject of K931096). This substantial equivalence determination by the FDA is based on the device having the same intended use, similar technological characteristics, and being as safe and effective as a legally marketed predicate device.

Therefore, I cannot fulfill your request to describe the acceptance criteria and study proving the device meets them with the provided input. The document focuses on the regulatory approval process (510(k)) and the device's substantial equivalence to existing products rather than providing detailed performance study data.

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