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510(k) Data Aggregation

    K Number
    K012717
    Device Name
    LIFE 2
    Manufacturer
    SYBRON DENTAL SPECIALTIES, INC.
    Date Cleared
    2001-10-25

    (71 days)

    Product Code
    EJK
    Regulation Number
    872.3250
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    LIFE 2

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

    Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques.

    Device Description

    Life 2 is a hard setting Calcium Hydroxide cavity liner and pulp capping agent to be used in conjunction with all permanent restorative techniques. Life 2 is a two-part, base/catalyst paste/paste system. The two-part system is packaged in tubes. The product is available in two viscosities, Regular Set and Fast Set.

    AI/ML Overview

    The provided text is a 510(k) summary for a dental device called "Life 2". It outlines the device description, intended use, and claims of substantial equivalence to a predicate device. However, it does not contain any information about acceptance criteria, device performance studies, sample sizes, expert ground truth establishment, adjudication methods, MRMC studies, or standalone algorithm performance.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided input. The document is solely for regulatory submission and does not detail performance testing results.

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