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510(k) Data Aggregation

    K Number
    K033760
    Device Name
    ONE COAT SE BOND
    Manufacturer
    COLTENE/WHALEDENT INC.
    Date Cleared
    2004-01-23

    (52 days)

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

    ONE COAT SE BOND

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

    One Coat SE Bond, a self etching dental adhesive, is indicated for the following:

    • The bonding of indirect restorations (inlays, onlays, veneers, when used with . lightcure or dual cure luting cements) to tooth structure.
    • The bonding of direct fillings of composite or compomer. .
    • The bonding of composite to amalgam. .
    • The repairing of metal/ceramic, ceramic or composite restorations. .
    • The sealing of sensitive teeth. .
    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter for a dental adhesive, not a study report or a document describing acceptance criteria and device performance. Therefore, I cannot extract the requested information. The document primarily focuses on regulatory approval rather than technical study details.

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