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510(k) Data Aggregation

    K Number
    K950261

    Validate with FDA (Live)

    Device Name
    DEVICE FOR PROVIDING QUICK COUPLING FOR DENTAL PROSTHESES
    Manufacturer
    DR. JOSEPH E. GRASSO, D.D.S.
    Date Cleared
    1997-09-09

    (960 days)

    Product Code
    DZE
    Regulation Number
    872.3640
    Type
    Traditional
    Panel
    Dental
    Age Range
    All
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticPediatricDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Not Found

    Device Description

    Device For Providing Quick Coupling For Dental Prostheses

    AI/ML Overview

    The provided text is a letter from the FDA to Dr. Joseph E. Grasso regarding the substantial equivalence of a "Device For Providing Quick Coupling For Dental Prostheses" (K950261).

    This letter serves as a premarket notification approval and does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, or expert qualifications.

    Therefore, it is impossible to answer any of the questions from the input based on the provided text.

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