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510(k) Data Aggregation

    K Number
    K200798
    Device Name
    G-CEM ONE
    Manufacturer
    GC America Inc.
    Date Cleared
    2020-11-24

    (243 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Cementation of all types of all ceramic, resin and metal-based inlays, onlays, crowns and bridges. 2. Cementation of metal, ceramic, fiber posts, and cast post and cores. 3. Cementation of all ceramic and composite veneers. 4. Final cementation of crowns and bridges on implant abutments.
    Device Description
    G-CEM ONE is a dual-cured self-adhesive resin cement with a tooth primer, G-CEM ONE ADHESIVE ENHANCING PRIMER. The mixed cement hardens through polymerization. The adhesive component is an acidic monomer which also can polymerize with frame-forming monomers. This copolymerizing reaction provides higher physical strength than resin-modified glass ionomer cements. Using the primer on the prepared tooth, surface modification and cement polymerization are promoted and hardened along with the cement. The cement syringe consists of Paste A and B, which are filled in a one-body/two chamber syringe. Both pastes are automixed with a mixing tip and applied directly to restorations or prepared cavity.
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    K Number
    K200682
    Device Name
    BZF-29
    Manufacturer
    GC America Inc.
    Date Cleared
    2020-10-02

    (200 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    BZF-29 is a two component (PRIMER and ADHESIVE), light-cured bonding agent suitable for: - Bonding of light cured composites and acid modified composites (compomers) to tooth structure. - Bonding of dual cured luting and core build up composites to tooth structure as long as these materials are light cured. - Intraoral repairs of porcelain fused to metal crowns and composite veneer crowns with metal backing. - . Intraoral repairs of all ceramic crowns (except zirconia and alumina), hybrid resin jacket crowns, CAD/CAM hybrid resin crowns and composites. - . Intraoral repairs of porcelain fused to zirconia crowns, porcelain fused to alumina crowns and full zirconia crowns. - . Treatment of hypersensitive teeth.
    Device Description
    BZF-29 is a two component, light-cured bonding agent to bond light-cured composite resins to tooth structure, composites, hybrid ceramics, ceramics and metal surfaces, and for the treatment of hypersensitive teeth.
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    K Number
    K193113
    Device Name
    GC Temp Print
    Manufacturer
    GC America Inc.
    Date Cleared
    2020-07-09

    (240 days)

    Product Code
    EBG
    Regulation Number
    872.3770
    Why did this record match?
    Applicant Name (Manufacturer) :

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Fabrication of temporary crowns, bridges, inlays, onlays and veneers 2. Fabrication of long-term temporary restorations
    Device Description
    GC Temp PRINT is 3D printable light curing composite for temporary crown and bridge. The device consists of a paste delivered in a bottle. GC Temp PRINT is fabricated with certain Digital Light Processing/Stereolithography Apparatus (DLP/SLA)a` 3D printers and post cured with light curing device into dental restorations, which are then bonded to tooth structure with adhesive temporary cement.
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    K Number
    K193484
    Device Name
    GC Fuji Triage EP
    Manufacturer
    GC America Inc.
    Date Cleared
    2020-07-02

    (198 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Pit & Fissure Sealant and Root Surface Sealant 2. Hypersensitivity due to abrasion and early non-cavitated lesions 3. Protection immature enamel 4. Temporary filling including endodontic access
    Device Description
    GC Fuji Triage EP is a bioactive glass ionomer for temporary restorative material. The device consists of powder and liquid filled in a capsule and is mixed with a capsule mixer. Then, the mixture is applied directly to a cavity with a capsule applier. As an additional improvement, a proprietary elongation tip can be attached to the capsule nozzle which enables access to small or deep cavities. GC Fuji Triage EP contains CPP-ACP (casein phosphopeptide - amorphous calcium phosphate) in the formulation. CPP-ACP was added to moderate the strength of cement for its use and provide a source of Ca+ and HP04-2. CPP-ACP was chosen as the additive for regulating the strength because it does not interfere with the setting reaction of the material.
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    K Number
    K192260
    Device Name
    everX Flow
    Manufacturer
    GC America Inc.
    Date Cleared
    2019-11-22

    (93 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    everX Flow is a reinforcing dentin replacement material suitable for: - 1. All direct composite restorations including large posterior cavities. - 2. Deep cavities and endo-treated teeth. - 3. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended. - 4. Core build-up
    Device Description
    everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.
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    K Number
    K182854
    Device Name
    GC FujiCEM 2 (Improved)
    Manufacturer
    GC America Inc.
    Date Cleared
    2019-07-11

    (274 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - -Cementation of metal-based inlays, onlays, crowns and bridges - -Cementation of resin inlays, onlays, crowns and bridges - Cementation of all ceramic inlays - - -Cementation of high strength (e.g. zirconia based, lithium disilicate) ceramic onlays, crowns and bridges - Cementation of metal, ceramic and fiber posts -
    Device Description
    GC FujiCEM 2 (Improved) is a resin modified glass ionomer luting cement. The device is composed of the two pastes, Paste A and Paste B, packaged in an automix dual barrel syringe.
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    K Number
    K180917
    Device Name
    GC Acrylic Primer
    Manufacturer
    GC America Inc.
    Date Cleared
    2018-11-20

    (225 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Increases the adhesiveness of light-curing composites to conventional acrylic resins used in dental laboratory procedures (e.g., modification of denture teeth/denture base resins)
    Device Description
    GC ACRYLIC PRIMER is a primer which raises the adhesiveness to acrylic resin and composite resin. GC ACRYLIC PRIMER is intended to use for bonding acrylics to acrylic resin, composite to composite resin, and acrylics to composite resin respectively.
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    K Number
    K181011
    Device Name
    AIM2
    Manufacturer
    GC America Inc.
    Date Cleared
    2018-07-12

    (86 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    AIM2 is a silicone impression material for taking oral impressions.
    Device Description
    AIM2 is a VPS silicone impression material. The components consist of the base silicone paste and the catalyst silicone paste that are extruded from a cartridge and are automixed with a mixing tip. AIM2 is available in one viscosity. The cartridge is made of high density polyethylene and the cap is made of polypropylene. The mixing tip is made of polypropylene.
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    K Number
    K172382
    Device Name
    GC Fuji Direct
    Manufacturer
    GC America Inc.
    Date Cleared
    2018-04-02

    (237 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Class III and V restorations 2. Restoration of primary teeth 3. Core build-up 4. Cases where radiopacity is required 5. Base material for Class I and Class II cavities using a sandwich laminate technique.
    Device Description
    GC Fuji Direct is a light-cured resin-modified restorative glass ionomer cement. The device consists of two pastes filled in a Paste Pak Cartridge. Paste A and B are dispensed with Paste Pak Dispenser II and hand mixed. Paste A and B can also be automixed by attaching the GC Fuji Direct Mixing Tip to the Paste Pak Dispenser II and applied directly to the prepared cavity. The bioactive material sets by acid-base reaction of fluoroalumino-silicate glass and Polyacrylic acid, and polymerization of methacrylate monomers.
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    K Number
    K173500
    Device Name
    NMF004A
    Manufacturer
    GC America Inc.
    Date Cleared
    2018-03-08

    (115 days)

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

    GC America Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Liner or base 2. Blocking out undercuts 3. Repair of (in) direct aesthetic restorations, temporary crown & bridge, defect margins are in enamel 4. Sealing hypersensitive areas 5. Fissure sealant 6. Direct restorative for Class I, II, III, IV, V cavities 7. Core build-up
    Device Description
    NMF004A is a light cured nano-filled radiopaque composite resin filled in a syringe. The device is used for the restorations of both anterior and posterior teeth. The material is available in 30 shades.
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