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510(k) Data Aggregation

    K Number
    K250156
    Device Name
    Choice 2 DC
    Manufacturer
    Bisco, Inc
    Date Cleared
    2025-07-11

    (171 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K251470
    Device Name
    ResiCem EX
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2025-07-11

    (59 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Device Description
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    K Number
    K250566
    Device Name
    EsCem RMGI
    Manufacturer
    Spident Co., Ltd.
    Date Cleared
    2025-06-20

    (114 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Final cementation of - Metal inlays, onlays, crowns and bridges - Resin inlays, onlays, crowns and bridges - Ceramic inlays - Zirconia crowns and bridges - Metal, ceramic and fiber posts
    Device Description
    EsCem RMGI is a radiopaque resin modified glass ionomer luting cement corresponding to ISO 9917-2, Class 3. This product facilitates the removal of excess cement through the tack-cure option, allowing for quick treatment. The contents consisting of base and catalyst are provided in a dual syringe and are used to cement indirect restoration by mixing the two types of paste.
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    K Number
    K242366
    Device Name
    OverCEM SA Universal; OverCEM SA Translucent; OverCEM SA Opaque; OverCEM Ti-Abutment; OverCEM Cer-Abutment
    Manufacturer
    Overfibers S.r.l.
    Date Cleared
    2025-01-10

    (154 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    1. Definitive cementation of inlays, onlays, crowns and bridges, in ceramic or zirconia, composite or metal; 2-3 unit Maryland bridges and 3-unit inlay/onlay bridges (to be avoided for patients with bruxism or periodontitis). 2. Definitive cementation of endocanal posts. 3. Definitive cementation of ceramic, zirconia, composite or metal restorations on implant abutments and natural teeth. 4. Definitive cementation of zirconium oxide superstructures for two-unit abutments
    Device Description
    OverCEM is dual-curing, self-adhesive resin luting cement. The components consists of Paste A and B, which are filled in a one-body syringe. Both pastes are automixed with a mixing tip. The operating principle of the device is based on two reactions, one self-curing. OverCEM is designed to strongly and stably connect reconstruction materials and endocanal posts to patients' teeth or implants.
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    K Number
    K240714
    Device Name
    Insure® Universal; Insure® Universal Automix
    Manufacturer
    Cosmedent Inc.
    Date Cleared
    2024-07-24

    (131 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Insure® Universal Cementation of ceramic and composite veneers, inlays and onlays with a thickness <2mm and sufficient translucency. Insure® Universal Automix Cementation of ceramic and composite inlays, onlays, veneers, crowns and bridges
    Device Description
    Not Found
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    K Number
    K241204
    Device Name
    TopCEM-Veneer Light Cure Veneer Cement
    Manufacturer
    Rizhao HuGe Biomaterials Company, Ltd.
    Date Cleared
    2024-06-28

    (59 days)

    Product Code
    EMA, EBF
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    TopCEM-Veneer Light Cure Veneer Cement is used for permanent cementation of veneer made from materials of porcelain/ceramic and composites.
    Device Description
    TopCEM-Veneer Light Cure Veneer Cement is a visible light curing cementation system that is designed for use with porcelain/ceramic and composite veneer restorations. The simple and versatile shade selections allow this material to be used with a wide range of veneer cases. The principal organic components are mixtures of dental methacrylate resins (TEGDMA, EBP ADMA and UDMA). The inorganic filler loading is about 40% by volume having particle size range of about 0.01 to 5 microns. Light Cure Veneer Cement is radiopaque, allowing for easy identification on radiographs. It is classified as Type 2 Class 2 Group 1 in accordance with ISO 4049:2019, which belongs to materials whose use requires the energy to be applied intro-orally.
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    K Number
    K240888
    Device Name
    Calibra Abutment Resin Cement
    Manufacturer
    Dentsply Sirona
    Date Cleared
    2024-04-02

    (1 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Calibra Abutment Resin Cement is indicated for the cementation of: Extraoral assembly of prosthetic components, e.g., structures made of ceramic or zirconia onto custom or pre-fabricated titanium/titanium alloy or zirconia bases/implant inserts/abutments, e.g., InCoris ZI and CEREC Tessera™ Abutment Block prostheses and mesostructures to TiBases.
    Device Description
    Calibra Abutment Resin Cement is a two-component, self-cure, high strength self-adhesive cement. Calibra Abutment Resin Cement has the ability to bond to titanium and is chemically compatible with silanated ceramic materials, making it suitable for extraoral assembly of prosthetic components. This self-cure only, opaque shade has been optimized for extraoral assembly when blocking of metal graying or show-through is desired. Cured Calibra Abutment Resin Cement is essentially hydrophobic, minimizing post-cure water sorption, solubility and hygroscopic expansion.
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    K Number
    K233161
    Device Name
    BeautiLink SA
    Manufacturer
    Shofu Dental Corporation
    Date Cleared
    2023-09-28

    (1 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Cementation of all-ceramic, composite and metal restorations Post cementation
    Device Description
    Not Found
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    K Number
    K231552
    Device Name
    Dia-Cem
    Manufacturer
    Diadent Group International
    Date Cleared
    2023-07-28

    (59 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    - Resin crowns, bridges, inlays and onlays - Glass Ceramic, Porcelain crowns, inlays and onlays(includes alumina and zirconia) - Metal crowns, bridges, inlays and onlays(includes porcelain-fused-to-metal and composite-to-metal) - Metal(prefabricated or cast) and fiber posts
    Device Description
    Dia-Cem is a radiopaque resin cement that can be used in self-cure or light-cure mode. It corresponds to type 2 and 3 of ISO 4049 and contains more than 60% of inorganic filler. Dia-Cem shows high bonding strength on various materials, yet excess material can be easily removed. 3 different shades are available: TR, A2, and A3O.
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    K Number
    K214076
    Device Name
    EsCem
    Manufacturer
    SPIDENT CO., LTD.
    Date Cleared
    2022-12-19

    (357 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Product Code :

    EMA

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Final cementation of all-ceramic, metal-based inlays, onlays, posts, crown and bridge
    Device Description
    EsCem is a dual-cured resin cement that can be self-etched and self-adhesive. It is classified as type 2 and class 3 according to ISO 4049. It is easy to handle with 'one step' system that does not need pre-treatment process, and it is easy to remove excess cement, so it is possible to perform quick operation. It is also easy to identify because it has a radio-opacity(1.2mm Al). And it offers various shades for aesthetics and color stable.
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