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510(k) Data Aggregation

    K Number
    K172169
    Device Name
    Pulpdent (Activa) Pit and Fissure Sealant with MCP
    Manufacturer
    Pulpdent Corporation
    Date Cleared
    2018-01-05

    (171 days)

    Product Code
    EBC,EBF
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K153249,K020287
    Why did this record match?
    Device Name :

    Pulpdent (Activa) Pit and Fissure Sealant with MCP

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

    Pulpdent's Activa Pit and Fissure Sealant with MCP is intended to seal pit and fissure depressions/faults in the enamel, in the biting surfaces of teeth. For dental professional use only.

    Device Description

    Activa Pit and Fissure Sealant is a light cured, flowable dental sealant material, available in a single barrel syringe. This sealant is designed with MCP (Modified Calcium Phosphate); it releases calcium, phosphate, and fluoride ions into the oral environment. It contains no Bisphenol A, no BisGMA, and no BPA derivatives.

    AI/ML Overview

    This document is a 510(k) premarket notification for a dental pit and fissure sealant. It does not describe an AI/ML-driven medical device, and therefore the requested information regarding acceptance criteria and study data for an AI/ML device is not present in the provided text.

    The document discusses substantial equivalence to a predicate device based on material composition, intended use, and physical properties, not on performance metrics of an AI algorithm.

    Therefore, I cannot extract the information required by your prompt from the provided text.

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