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510(k) Data Aggregation

    K Number
    K050871
    Device Name
    RIVA PROTECT
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-06-10

    (65 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RIVA PROTECT

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

    Pit and fissure sealing. Root/tooth surface protection and hypersensitivity prevention. Temporary restorations in non load-bearing applications, temporary endodontic sealing.

    Device Description

    Not Found

    AI/ML Overview

    This document does not contain information about acceptance criteria or a study proving that a device meets acceptance criteria. The document is a 510(k) premarket notification letter from the FDA regarding the Riva Protect device, classifying it and permitting its marketing. It does not include details on performance testing or clinical studies.

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