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K Number
K994181
Device Name
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
Manufacturer
PULPDENT CORP.
Date Cleared
2000-02-29

(81 days)

Product Code
LBH
Regulation Number
872.3260
Type
Traditional
Panel
DE
Reference & Predicate Devices
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

Pulpdent Cavity Preparation II 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 II. an aqueous solution of chlorhexidine gluconate, 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. Pulpdent makes no claim as to the antimicrobial effect of chlorhexidine gluconate.

Pulpdent Cavity Preparation II with Fluoride combines all the features of Pulpdent Cavity Preparation II with the addition of sodium fluoride as a stabilizer. Pulpdent makes no therapeutic claim with regard to the addition of fluoride.

Device Description

Pulpdent Cavity Preparation II. an aqueous solution of chlorhexidine gluconate, cleans and moistens tooth structure to facilitate bonding with adhesives that require moist surfaces. It can also be used prior to sealing dentin tubules.

AI/ML Overview

I am sorry, but the provided text does not contain the information required to answer your request. The document is a 510(k) clearance letter from the FDA for a product called "Pulpdent Cavity Preparation II". It discusses regulatory approval and indications for use but does not present any acceptance criteria, study data, sample sizes, expert qualifications, or ground truth information relevant to a device performance study.

§ 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.