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510(k) Data Aggregation

    K Number
    K052033
    Device Name
    VINTAGE ZR
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2005-11-18

    (114 days)

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

    VINTAGE ZR

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

    Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.

    Device Description

    Vintage ZR is high fusing porcelain used for fabricating ZrO2 framework bonded all ceramic restorations.

    AI/ML Overview

    The provided documents are a 510(k) clearance letter and an "Indications for Use" statement for a dental device called "Vintage ZR." These documents do not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment. This type of information is typically found in the full 510(k) submission, which is not provided here.

    Therefore, I cannot answer your request based on the provided input. The documents confirm that "Vintage ZR" is a high fusing porcelain for fabricating ZrO2 framework bonded all-ceramic restorations and that it has received 510(k) clearance (K052033) from the FDA.

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