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510(k) Data Aggregation

    K Number
    K203672
    Device Name
    MAZIC Claro CAD and MAZIC Claro Press
    Manufacturer
    Vericom Co., Ltd.
    Date Cleared
    2021-07-01

    (197 days)

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

    Vericom Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    MAZIC Claro Press is an all-ceramic system for the creation of Occlusal veneers Thin Veneers Veneers Inlays Onlays Crowns in the anterior and posterior region 3-unit bridges in the anterior region 3-unit bridges in the premolar region up to the second premolar as the terminal abutment Crown, splinted crown or 3 unit bridge up to the second premolar placed on top of an implant abutment. MAZIC Claro CAD is a CAD/CAM machinable glass ceramic based on lithium disilicate for the preparation of full ceramic crowns, inlays, onlays and full ceramic 3-unit anterior bridges.
    Device Description
    The MAZIC Claro Press, dental glass ceramic ingot, is to make dental restorative prosthesis such as inlays, onlays, veneers, crowns and bridges. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through regular press process. The MAZIC Claro CAD, dental glass ceramic block, is to make dental restorative prosthesis such as inlays, onlays, veneers and crowns. Having a variety of shade, the user can choose a suitable color that matches the natural teeth of the patient. The prosthesis can be made through milling procedure by dental CAD/CAM.
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    K Number
    K193260
    Device Name
    U-Cem Premium & MAZIC Cem
    Manufacturer
    Vericom Co., Ltd.
    Date Cleared
    2020-08-21

    (269 days)

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

    Vericom Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - 1. Luting metal crowns, bridge, inlay and including porcelain-fused-to-metal and composite-to-metal varieties - 2. Luting resin crowns, bridges, inlays, onlays and veneers - 3. Luting metal or non-metal/fiber posts - 4. Luting orthodontic appliances - 5. Luting porcelain inlays, onlays, crowns and veneers (includes alumina and zirconia)
    Device Description
    The U-Cem™ Premium and the MAZIC® Cem are dual-cured self-adhesive resin cement. The U-Cem™ Premium and the MAZIC® Cem are the same product yet with different label design for different volume packages as shown below. The brand name, MAZIC® Cem, is specifically for 8.5g. It is fluoride-releasing paste type, and has radiopaque. U-Cem™ Premium is available in both Automix and Double Dispenser types, and offers three different shades: Clear, Universal, and Opaque for esthetics. It is used for cementation of ceramics, metals or composite inlays, onlays, crowns, bridges, posts and screws.
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    K Number
    K170950
    Device Name
    Well-Root ST
    Manufacturer
    Vericom Co., Ltd.
    Date Cleared
    2017-12-20

    (264 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vericom Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Permanent sealing of root canal
    Device Description
    Well-Root™ ST is a convenient premixed ready-to use composition which requires the presence of water to set and harden. The device is contained in a plastic syringe and the system includes a plunger, disposable tips, and a holder.
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    K Number
    K163346
    Device Name
    MAZIC Duro
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2017-03-17

    (108 days)

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

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Fabrication of inlays, onlays, veneers and crowns
    Device Description
    MAZIC™Duro, a dental restorative material, is a radiopaque, block type, hybrid ceramic that is intended for the fabrication of inlays, onlays, veneers and crowns. The device can be matched to the patient's tooth shade and is intended for use in dental CAD/CAM milling procedures.
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    K Number
    K160377
    Device Name
    V-varnish Premium
    Manufacturer
    Vericom Co., Ltd.
    Date Cleared
    2016-12-02

    (296 days)

    Product Code
    LBH
    Regulation Number
    872.3260
    Why did this record match?
    Applicant Name (Manufacturer) :

    Vericom Co., Ltd.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For treatment of dentinal hypersensitivity secondary to exposed dentin and root surfaces
    Device Description
    V-varnish™ Premium is cavity varnish containing 5% sodium fluoride(F ion: 22,600ppm). It is applied to teeth for the purpose of treatment dentinal hypersensitivity. V-varnish™ Premium consists of rosin which adheres to the surface of the teeth, seals exposed dentin tubules. V-varnish™ Premium has four flavors such as bubblegum, strawberry, melon and mint and two colors(clear and white). It is packed in single dose package allows easy mixing and application.
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    K Number
    K152615
    Device Name
    Vonflex S
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2016-11-03

    (416 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions - Impression of inlay, crown, bridge and partial denture etc.
    Device Description
    Vonflex S™, as the additional polymerization silicone type, is composed of a two component (base and catalyst, mixing ratio 1:1) hydrophilic vinyl polysiloxane impression material for all dental impression techniques. Vonflex S™ consists of light-bodied, medium-bodied or heavy-bodied consistencies in delivery systems of cartridges and/or tubes. It has normal set and fast set that would be desired by the operator.
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    K Number
    K140966
    Device Name
    VONFLEX S BITE
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2014-08-15

    (122 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Standard bite registrations in the end bite position - - Portrayal of antagonists - - Coating of bite forks - - Key material for needle point registration - - -Production of small model segments
    Device Description
    Not Found
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    K Number
    K103164
    Device Name
    VONFLEX HEAVY, VINFLEX LIGHT
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2010-11-10

    (14 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Impression material in a dual phase impression technique - Precise duplication of models - Capturing multiple unit impressions - All impression techniques where the operator needs a heavy or low viscosity material
    Device Description
    Vonflex™ Heavy/ Vonflex™ Light as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low deformation, helping to make precise impression taking.
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    K Number
    K103121
    Device Name
    ECO-S
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2010-10-26

    (4 days)

    Product Code
    EBC
    Regulation Number
    872.3765
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Pit and fissure sealant
    Device Description
    Eco-S™ is a single part, light curing, pit and fissure sealant. It is based on methacrylate resin chemistry. It can be used as a pit and fissure sealant. It is intended to be used on posterior teeth and is not permanent.
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    K Number
    K091267
    Device Name
    VONFLEX PUTTY
    Manufacturer
    VERICOM CO., LTD.
    Date Cleared
    2009-05-06

    (6 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Why did this record match?
    Applicant Name (Manufacturer) :

    VERICOM CO., LTD.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Two step putty/wash impression technique - One step putty/wash impression technique - Two step putty/wash impression technique using a foil (plastic putty spacer) - One step putty impression technique for forming functional peripheries
    Device Description
    Vonflex™ Putty, as the additional polymerization silicone type, is a rubber impression material that makes oral tissue shape precisely. And it is very easy to handle and has low shrinkage, helping to make precise impression taking.
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