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510(k) Data Aggregation

    K Number
    K191133
    Device Name
    KATANA Cleaner, KATANA Cleaner (Trial)
    Manufacturer
    Kuraray Noritake Dental Inc.
    Date Cleared
    2019-10-08

    (162 days)

    Product Code
    PME, LBH
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - [1] Cleaning of contaminated glass ceramic, zirconia, resin restorations, metal restorations and fiber post after intraoral try-in. - [2] Cleaning for contaminated prepared tooth (cavity, root canal and tooth abutment), and implant abutment
    Device Description
    This subject device is a dental cleaning agent suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. It is also suitable for cleaning a contaminated prepared cavity, root canal, and tooth/ implant abutment. It is used in helping to achieve optimal adhesive results.
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    K Number
    K163171
    Device Name
    CeraClean
    Manufacturer
    Bisco, Inc.
    Date Cleared
    2017-04-14

    (151 days)

    Product Code
    PME
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    CeraClean is an extraoral cleaner of pre-treated ceramic, zirconia and metal restoration surfaces which have been contaminated during intraoral try-in.
    Device Description
    CeraClean is used outside the mouth, as an extraoral cleaning gel suitable for non-abrasive cleaning of the bonding surfaces of prosthetic restorations after intraoral try-in. CeraClean is applied through a single-use tip or application to the prosthetic restorations and rinsed off prior to the application of a primer or cement for final placement of the restoration.
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    K Number
    K152322
    Device Name
    Resolve 2.0
    Manufacturer
    DENALI CORPORATION
    Date Cleared
    2015-12-16

    (121 days)

    Product Code
    PME, LBH
    Regulation Number
    872.3260
    Why did this record match?
    Product Code :

    PME

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Resolve 2.0 is recommended for use on dental restorations, external to the mouth, prior to insertion into the mouth. After applying Resolve 2.0 to cleanse the restoration, the surface of the restoration should be washed thoroughly with water, and then air dried before placement in the mouth. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
    Device Description
    Resolve 2.0 is a thin, non-alcohol based gel containing chlorhexidine gluconate. This thin gel because of its water solubility, abrasive action and low viscosity when applied to dental restorations, acts as a cleaning agent. This gel is provided in easy to use syringes and floc-tipped applicator tips to precisely deliver the gel to the intended areas. For Use only by a Licensed Dentist. Rx Use Only. Non-sterile.
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