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510(k) Data Aggregation

    K Number
    K111855
    Device Name
    HY-BOND RESIGLASS
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2011-11-17

    (141 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Hy-Bond Resiglass is intended for cementation of restorations (including inlay, crown and bridge) made of metal, ceramics (porcelain) and resin to natural teeth. This product is also intended for cementation of orthodontic appliances (metal bracket, ceramics bracket, etc.) to natural teeth.
    Device Description
    Not Found
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    K Number
    K110235
    Device Name
    BEAUTIBOND MULTI
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2011-05-13

    (107 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeautiBond Multi is intended for bonding composite resin to cavity or lesion including dentin. It is also intended for bonding composite resin to ceramics, composite resin, and metals to repair fractured restorations or prostheses.
    Device Description
    Not Found
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    K Number
    K110252
    Device Name
    BEAUTIBOND MULTI PR PLUS
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2011-05-13

    (105 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeautiBond Multi PR Plus is dental adhesive to ceramic, consisting primarily of surface treatment material (silane coupling agent). This product is intended for bonding composite resin to ceramics other than alumina and zirconia or composite resin to repair fractured restorations or prostheses.
    Device Description
    Not Found
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    K Number
    K101603
    Device Name
    BEAUTIFIL FLOW PLUS
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2010-08-23

    (76 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Beautifil Flow Plus is a light-curing dental filling material having low viscosity intended to directly restore cavities and lesions (except for root canal filling), and to repair fractured artificial crowns.
    Device Description
    Beautifil Flow Plus is a light-curing dental filling material having low viscosity.
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    K Number
    K101621
    Device Name
    LITE ART
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2010-08-23

    (75 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    LITE ART is dental resin-based stain material intended to harmonize the color of polymer-based C&B composite resin restorations with surrounding natural dentition. Specific usage of this product is as follows: 1) To characterize and modify C&B composite resin or acrylic resin restorations and 2) To characterize and modify hard resin teeth and acrylic resin teeth.
    Device Description
    Not Found
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    K Number
    K093559
    Device Name
    VINTAGE MP
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2010-03-03

    (105 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    VINTAGE MP is paste or powder porcelain intended to fabricate metal-ceramic restorations. It is used in conjunction with precious alloys for metal-ceramic restoration, metals for metal-ceramic restoration and stain materials for metalceramic restoration in order to produce natural looking restorations and prostheses.
    Device Description
    VINTAGE MP is paste or powder porcelain
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    K Number
    K082744
    Device Name
    BEAUTIBOND
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2008-12-11

    (84 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BeautiBond is a light-cured single-component dental adhesive intended to bond dental filling material to cavity or lesion including dentin or enamel for filling restorations of both anterior and posterior teeth.
    Device Description
    BeautiBond is a light-cured single-component dental adhesive.
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    K Number
    K080517
    Device Name
    RESICEM
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2008-06-11

    (107 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    RESICEM is a dual cured, visible light cured, and self cured dental adhesive resin cement and is intended for adhesion between any two of the following: dental restoration, dental restorative material, dental device, and natural teeth.
    Device Description
    Not Found
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    K Number
    K080834
    Device Name
    VINTAGE ART
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2008-06-11

    (78 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Why did this record match?
    Applicant Name (Manufacturer) :

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Vintage Art is dental ceramic stain and is used for adjusting the shade of dental ceramic restorations or prostheses. It can reproduce natural-teeth like crown restorations and prostheses when built up on dental metal ceramic porcelain, dental porcelain, dental ceramic core material and porcelain teeth.
    Device Description
    Vintage Art is dental ceramic stain.
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    K Number
    K080068
    Device Name
    BEAUTIFIL OPAQUER
    Manufacturer
    SHOFU DENTAL CORP.
    Date Cleared
    2008-02-28

    (49 days)

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

    SHOFU DENTAL CORP.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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