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510(k) Data Aggregation

    K Number
    K062064
    Device Name
    RIVA BOND LC
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2006-11-09

    (112 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    RIVA BOND LC

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • · For direct bonding of composite resin to dentin and enamel.
    • · For direct bonding of composite resin to dentin and enamel in the co-cured technique.
    • · For direct bonding of composite resin to GI self cure or GI light cure base base base on and enamel in the "sandwich" technique.
    • · For · sealing to hypersensitive cervical areas and root surfaces of teeth.
    Device Description

    Not Found

    AI/ML Overview

    I am sorry, but the provided text does not contain information about acceptance criteria, device performance, or any studies conducted on the Riva Bond LC device. The document is a 510(k) premarket notification letter from the FDA, confirming the substantial equivalence of the Riva Bond LC to a legally marketed predicate device. It defines the indications for use but does not include details about performance studies or acceptance criteria.

    Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets the acceptance criteria based on the provided text.

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