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510(k) Data Aggregation

    K Number
    K021437
    Device Name
    SECURE SOFT
    Manufacturer
    IMTEC CORP.
    Date Cleared
    2002-07-19

    (74 days)

    Product Code
    EBI
    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

    SECURE SOFT is intended for use as permanently soft relining for total and partial dentures.

    • To relieve pressure from pressure spots .
    • · To dam the palatal vibrating line in cases of flabby ridge and insufficient adhesion
    • To cushion sharp-edged alveolar processes .
    • . To support the healing process in implantology
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a dental device called "Secure Soft." This document does not contain any information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth methodologies. The letter primarily focuses on the regulatory determination of substantial equivalence to a predicate device.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study proving the device meets them based on the provided input. This information would typically be found in the 510(k) submission itself or in a separate study report, not in the FDA's clearance letter.

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