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510(k) Data Aggregation

    K Number
    K102257
    Device Name
    NANOCERAM- BRIGHT
    Manufacturer
    DMP LTD
    Date Cleared
    2010-11-19

    (101 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Anterior restorations (Class III, IV)
    • Posterior restorations (Class I, II)
    • Class V restorations (Cervical caries, root erosion, wedge shaped defects)
    • Veneering of discolored anterior teeth
    • Splinting of mobile teeth . : .
    • Repair of composite and ceramic veneers
    Device Description

    Not Found

    AI/ML Overview

    The provided text is a 510(k) premarket notification letter from the FDA regarding a dental restorative material called NANOCERAM-BRIGHT. This document is related to regulatory clearance and does not contain information about acceptance criteria, device performance studies, sample sizes, expert qualifications, or ground truth establishment.

    Therefore, I cannot provide the requested information based on the input text. The document confirms the device's regulatory classification and lists its intended uses but does not include any technical study details.

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