LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K990040
    Device Name
    CLEARFIL SE BOND
    Manufacturer
    KURARAY CO.
    Date Cleared
    1999-02-04

    (29 days)

    Product Code
    KLE
    Regulation Number
    872.3200
    Why did this record match?
    Applicant Name (Manufacturer) :

    KURARAY CO.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CLEARFIL SE BOND is indicated for the following applications: 1) Direct filling restorations using light-curing composite or compomer 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of hypersensitive and/or exposed root surfaces 4) Intraoral repairs of fractured facing crowns made of porcelain, hybrid ceramics and cured composite resin 5) Surface treatment of prosthetic appliances made of porcelain, hybrid ceramics and cured composite resin
    Device Description
    CLEARFIL SE BOND is classified into the resin tooth bonding agent, CFR 21 Section 872.3200, because it is a device composed of materials such as dimethacrylate monomers intended to painted on the interior of a prepared cavity of a tooth to improve retentive materials.
    Ask a Question

    Page 1 of 1