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510(k) Data Aggregation

    K Number
    K101104
    Device Name
    REMIN PRO
    Manufacturer
    VOCO GMBH
    Date Cleared
    2010-10-21

    (184 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    REMIN PRO

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

    VOCO Paste is intended to be used after professional tooth whitening, professional tooth cleaning and for prevention and control of hypersensitivities.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for VOCO Paste. The document is an FDA 510(k) clearance letter, which primarily addresses the substantial equivalence of the device to a legally marketed predicate device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the given input.

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