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510(k) Data Aggregation

    K Number
    K210189
    Device Name
    Pac-Dent Denture Base Resin
    Manufacturer
    Pac-Dent, Inc.
    Date Cleared
    2021-07-28

    (184 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    Pac-Dent Denture Base Resin

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

    Pac-Dent Denture Base resin is a light-curable resin indicated for fabrication and repair of full and partial removable dentures and baseplates. The material is an alternative to traditional heat-curable and auto polymerizing resins.

    Device Description

    Pac-Dent Denture Base resin is a light-curable resin.

    AI/ML Overview

    The provided text is a clearance letter from the FDA for a dental device, specifically a "Pac-Dent Denture Base Resin." It does not contain information about the acceptance criteria or a study proving that an AI/ML device meets those criteria. The document is strictly a regulatory clearance for a physical medical device (denture resin), not a software or AI-driven device.

    Therefore, I cannot answer the questions regarding acceptance criteria, device performance, sample sizes, ground truth, expert qualifications, or MRMC studies for an AI/ML device, as this information is not present in the provided text.

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