(75 days)
Pulpdent Cavity Preparation I 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 Preparation I, an aqueous solution of the disodium salt of ethylenediaminetetraacetic acid dihydrate and benzalkonium chloride, 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 step reduces micro leakage sensitivity in teeth undergoing treatment or restoration. Pulpdent makes no claim as to the antimicrobial effect of benzalkonium chloride.
Pulpdent Cavity Preparation I with Fluoride has the advantage of increased stability from the addition of sodium fluoride. Pulpdent makes no therapeutic claim with regard to the addition of sodium fluoride.
Pulpdent Cavity Preparation I, an aqueous solution of the disodium salt of ethylenediaminetetraacetic acid dihydrate and benzalkonium chloride
The provided documents, K994182, are a 510(k) clearance letter and an Indications for Use statement for the "Pulpdent Cavity Preparation I" device. These documents do not contain information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert reviews as typically found in a clinical study report for an AI/software device.
The 510(k) clearance process focuses on demonstrating substantial equivalence to a previously marketed predicate device, rather than proving efficacy or performance through robust clinical trials with specific acceptance criteria as you've requested for an AI device.
Therefore, I cannot provide the requested information from these documents. The questions you've posed are generally applicable to the evaluation of AI/ML-driven medical devices, which typically undergo more rigorous performance testing and clinical validation studies than what is outlined in a traditional 510(k) for a chemical preparation like the Pulpdent Cavity Preparation I.
§ 872.3260 Cavity varnish.
(a)
Identification. Cavity varnish is a device that consists of a compound intended to coat a prepared cavity of a tooth before insertion of restorative materials. The device is intended to prevent penetration of restorative materials, such as amalgam, into the dentinal tissue.(b)
Classification. Class II (special controls). The device, when it is an external cleaning solution, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 872.9.