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510(k) Data Aggregation

    K Number
    K081273
    Device Name
    ULTRACAPS S
    Manufacturer
    SDI LTD.
    Date Cleared
    2008-07-10

    (66 days)

    Product Code
    OIV,EJJ,ELY
    Regulation Number
    872.3070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ULTRACAPS S

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

    Intended for tooth restorations as a treatment for dental carries and for interious for tooth restorations (Class I and Class II), when other materials or restoration techniques are not indicated. For professional use only.

    Device Description

    Not Found

    AI/ML Overview

    I am unable to answer this question. The provided document is a letter from the FDA to SDI Limited regarding the substantial equivalence of their device, Ultracaps S, to legally marketed predicate devices. This letter does not contain information about acceptance criteria, device performance, study design, or expert qualifications, which are necessary to answer the prompt.

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