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510(k) Data Aggregation

    K Number
    K991577
    Device Name
    NIC TONE ACRYLIC RESINS
    Manufacturer
    MANUFACTURERA DENTAL CONTINENTAL
    Date Cleared
    1999-09-22

    (139 days)

    Product Code
    EBI,EBG,OCL
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Nic Tone Acrylic Resins are used in the fabrication, repair or rebasing of complete or partial removable dentures, the fabrication of veneer crowns, the fabrication of orthodontic devices, and the fabrication of temporary crowns and bridges.

    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted. The document is a 510(k) premarket notification letter from the FDA regarding "Nic Tone Acrylic Resins," confirming its substantial equivalence to legally marketed predicate devices. It discusses regulatory classifications, general controls, and responsibilities of the manufacturer but does not delve into specific performance studies or acceptance criteria for the device itself.

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