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510(k) Data Aggregation

    K Number
    K024252
    Device Name
    MATCH MASTER LOW FUSION PORCELAIN
    Manufacturer
    DAVIS SCHOTTLANDER & DAVIS, LTD.
    Date Cleared
    2004-01-22

    (395 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    MATCH MASTER LOW FUSION PORCELAIN

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

    Match Master low fusing porcelain is to be used in conjunction with metal or pressable ceramic framework in the construction of crowns and/or bridgework.

    Device Description

    Not Found

    AI/ML Overview

    This document is a letter from the FDA to Davis Schottlander & Davis Limited regarding their device, Schottlander MATCH MASTER Low Fusing Porcelain. The letter states that the FDA has reviewed the company's premarket notification (510(k)) and determined that the device is substantially equivalent to legally marketed predicate devices.

    The document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the FDA's regulatory decision regarding market clearance based on substantial equivalence. Therefore, I cannot provide the requested information from the given text.

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