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Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.

Pulpdent CAVITY CLEANSER is a dental product used to cleanse and moisten cavity preparations prior to sealing the dentin tubules or placing an adhesive that bonds to damp tooth structure. It can be used under veneers, inlays, crowns, onlays, amalgams and composite resins. Recent studies have suggested that this cleansing step reduces microleakage sensitivity in teeth undergoing treatment or restoration.

Pulpdent CAVITY CLEANSER PLUS combines all the features of Pulpdent CAVITY CLEANSER with the addition of sodium fluoride.

This document is a 510(k) Premarket Notification for PULPDENT Cavity Cleanser and PULPDENT Cavity Cleanser Plus. It is a regulatory submission to the FDA, asserting substantial equivalence to existing predicate devices, rather than a study designed to establish acceptance criteria or device performance in the typical sense of a clinical trial or algorithm validation.

Therefore, the requested information pertaining to acceptance criteria, specific performance metrics, sample sizes for testing/training sets, expert adjudication, MRMC studies, or standalone algorithm performance cannot be extracted from this document, as these concepts are not applicable to this type of regulatory submission.

This document focuses on:

• Device Name: Pulpdent Cavity Cleanser and Pulpdent Cavity Cleanser Plus
• Predicate Devices: Ultradent UltraCid and UltraCid F, Ultradent Concepsis, Dental Therapeutics AB Tubulicid Plus, Tubulicid Blue Label, Tubulicid Red Label
• Description and Intended Use: To cleanse and moisten cavity preparations prior to sealing dentin tubules or placing an adhesive that bonds to damp tooth structure. Can be used under veneers, inlays, crowns, onlays, amalgams, and composite resins. The "Plus" version includes sodium fluoride.
• Comparison with Predicate Products: Stated to be "substantially equivalent in composition and intended use to the predicate products."
• Safety and Effectiveness: Stated that "The materials that make up these products are accepted by the Council on Dental Therapeutics and have been used safely in dental products for decades." References are provided in Exhibit 8 (not included in the provided text).

The FDA's response (MAR 19 1998) confirms that they "reviewed your Section 510(k) notification... and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." This is a regulatory finding, not a performance study.

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