Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K051796
    Device Name
    CLEARFIL TRI-S BOND SINGLE DOSE
    Manufacturer
    KURARAY MEDICAL KURASHIKI PLANT
    Date Cleared
    2005-08-09

    (35 days)

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

    KURARAY MEDICAL KURASHIKI PLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Clearfil tri-S bond Single dose is indicated for the following applications: 1) Direct restorations using light cured composite resin 2) Cavity sealing as a pretreatment for indirect restorations 3) Treatment of exposed root surfaces 4) Core build-ups using light- or dual-cured composite resin
    Device Description
    This device 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 be painted on the interior of a prepared cavity of a tooth to improve retention of restorative materials. The ingredients and composition of this device are the same as that of Clearfil tri-S bond (K042913) and it only differs in that it is filled in single dose tips (disposable tips).
    Ask a Question
    K Number
    K042929
    Device Name
    ESTENIA C&B
    Manufacturer
    KURARAY MEDICAL KURASHIKI PLANT
    Date Cleared
    2004-12-06

    (45 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Why did this record match?
    Applicant Name (Manufacturer) :

    KURARAY MEDICAL KURASHIKI PLANT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    ESTENIA C&B is indicated for the following applications for the restoring crowns and defects. 1) Facing cast crowns and facing cast bridges 2) Jacket crowns 3) Inlays and onlays 4) Bridges with frameworks
    Device Description
    This device is a polymer based material, used for fabricating prosthetic appliance such as facing cast crowns, facing cast bridges, jacket crowns, inlays, onlays or bridges with frameworks, and for repair of those prosthetic appliances made of resin based crown and bridge materials or porcelain.
    Ask a Question

    Page 1 of 1