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510(k) Data Aggregation

    K Number
    K050331
    Device Name
    ADHESIVE 1
    Manufacturer
    SOUTHERN DENTAL INDUSTRIES, INC.
    Date Cleared
    2005-03-24

    (42 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    ADHESIVE 1

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

    Direct bonding of light-cured composite and compomer materials, dentin sealing, direct bonding of light-cured composite to ceramics, composite, metals and amalgam.

    Device Description

    Not Found

    AI/ML Overview

    This is a letter from the FDA to a medical device manufacturer, indicating that their device, "Adhesive 1," has been found substantially equivalent to a legally marketed predicate device. This document does not contain information about acceptance criteria or a study proving the device meets acceptance criteria. It primarily focuses on the regulatory clearance for marketing the device.

    Therefore, I cannot extract the requested information regarding the acceptance criteria and the study that proves the device meets them from the provided text.

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