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510(k) Data Aggregation

    K Number
    K971284
    Device Name
    OPALDAM
    Manufacturer
    ULTRADENT PRODUCTS, INC.
    Date Cleared
    1997-06-03

    (57 days)

    Product Code
    EIG
    Regulation Number
    872.4565
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Product Code :

    EIG

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

    OpalDam resin is used to protect soft tissue adjacent to the teeth during in-office bleaching. OpalDam is used with Opalescence Xtra (35% hydrogen peroxide) "power" bleaching agent.

    Device Description

    OpalDam resin

    AI/ML Overview

    The provided text is a 510(k) clearance letter from the FDA for a device called "OpalDam." This type of document primarily confirms that a device is substantially equivalent to a legally marketed predicate device and does not typically include detailed information about acceptance criteria, comprehensive study results, sample sizes, or ground truth establishment as would be found in a clinical study report.

    Therefore,Based on the provided text, I cannot answer the request as the document is a 510(k) clearance letter, which does not contain the detailed study information needed to describe acceptance criteria and device performance. The letter confirms substantial equivalence but does not provide the specific data from clinical or performance studies.

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