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510(k) Data Aggregation

    K Number
    K153249
    Device Name
    Pulpdent Solo Flowable Composite with MCP
    Manufacturer
    Pulpdent Corporation
    Date Cleared
    2016-04-01

    (144 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K103585,K130223
    Why did this record match?
    Reference Devices :

    K103585

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Pulpdent Solo Flowable Composite with MCP is a fluoride, calcium and phosphate-releasing flowable composite used by dental professionals as a restorative, base and liner.

    Device Description

    Pulpdent Solo Flowable Composite with MCP is a light-cured, radiopaque, glass-filled resin with MCP (modified calcium phosphate filler) that releases calcium and phosphate ions into the oral environment and which may be formulated to release fluoride ions. Solo Flowable Composite with MCP contains no Bisphenol A, no BisGMA and no BPA derivatives. It is available in tooth shades, has low solubility, low water sorption and high physical properties.

    AI/ML Overview

    This document is a 510(k) summary for a dental product, Pulpdent Solo Flowable Composite with MCP. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than providing a detailed study proving performance against acceptance criteria for a new AI/software device.

    Therefore, the requested information (acceptance criteria, study details, sample sizes, expert qualifications, adjudication, MRMC, standalone performance, ground truth, training set size, etc.) is not available in the provided text as it pertains to a medical device's premarket notification, not an AI/software study.

    The document describes the device, its intended use, and compares its physical and chemical properties to two predicate devices to demonstrate that it is substantially equivalent and safe for market introduction. There is no mention of an algorithm, AI, or software development.

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