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510(k) Data Aggregation

    K Number
    K990736
    Device Name
    GC RELINE SOFT/EXTRA SOFT
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    1999-05-28

    (84 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GC RELINE SOFT/EXTRA SOFT

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

    GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

    Device Description

    GC Reline Soft / Extra Soft is a resilient material for making soft relinings of dentures. The product is composed of denture relining Soft/Extra Soft, Primer (Primer R and Primer M) and Modifier and Silicone Points. Two types are available, Soft and Extra Soft.

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria or a study proving device performance for "GC Reline Soft/Extra Soft". The document is a 510(k) clearance letter from the FDA, which determines substantial equivalence to a predicate device, allowing it to be marketed. It does not include details of performance studies, sample sizes, expert qualifications, or ground truth establishment.

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