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510(k) Data Aggregation

    K Number
    K200330
    Device Name
    RC-Prime Root Canal Preparation Cream
    Manufacturer
    Pac-Dent, Inc
    Date Cleared
    2020-07-06

    (147 days)

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

    RC-Prime Root Canal Preparation Cream

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

    RC-Prime Root Canal Preparation Cream is intended to be used by dental practitioners to cleanse and debride root canals for more efficient instrumentation during endodontic therapy.

    Device Description

    RC-Prime Root Canal Preparation Cream

    AI/ML Overview

    I am sorry, but the provided text does not contain the acceptance criteria or a study that proves a device meets such criteria. The document is an FDA 510(k) clearance letter for a dental product called "RC-Prime Root Canal Preparation Cream." It primarily discusses the regulatory classification, equivalence to predicate devices, and general controls provisions of the Act for marketing the device.

    There is no information regarding:

    • A table of acceptance criteria and reported device performance.
    • Sample sizes used, data provenance, or ground truth establishment for a test set.
    • Number or qualifications of experts.
    • Adjudication methods.
    • Multi-reader multi-case comparative effectiveness studies.
    • Standalone algorithm performance.
    • Ground truth type.
    • Training set sample size or how its ground truth was established.

    Therefore, I cannot fulfill your request based on the provided input.

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