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Pulpdent Cavity Preparation III is used by the dental professional as one step in the preparation of teeth for veneers, inlays, crowns, onlays, amalgam and composite resin restorations.

Pulpdent Cavity Preparations III, a solution of glutaraldehyde and water, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

Pulpdent Cavity Preparations III, a solution of glutaraldehyde and water, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules. Recent studies have suggested that this cleansing step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Sodium fluoride has been included in the formula for Pulpdent Cavity Preparation III to enhance the stability of the solution.

This document is a 510(k) clearance letter from the FDA for a dental device called "Pulpdent Cavity Preparation III". It states that the device is substantially equivalent to legally marketed predicate devices.

However, this document does not contain any information regarding acceptance criteria or the study that proves the device meets specific acceptance criteria.

The 510(k) clearance process by the FDA, especially for devices cleared in 2000, primarily focuses on demonstrating substantial equivalence to a predicate device. This often involves comparing device characteristics, indications for use, and sometimes performance data, but it typically does not require the submission or review of a comprehensive clinical study with predefined acceptance criteria in the way described in your request (e.g., specific sensitivity, specificity, or reader performance metrics).

Therefore, I cannot provide the requested information based on the text provided. The document outlines the regulatory approval for the device based on substantial equivalence, but not a performance study with acceptance criteria.

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