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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
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K120243,K153231
    Why did this record match?
    Device Name :

    G-CEM ONE

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    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.

    AI/ML Overview

    I am sorry, but the provided text is a 510(k) premarket notification for a dental cement (G-CEM ONE) and does not contain information about an AI/ML device.

    Therefore, I cannot extract the acceptance criteria or study details regarding AI performance as requested in your prompt. The document focuses on the physical and chemical properties of the dental cement and its biocompatibility, comparing it to predicate dental cements.

    Specifically, the document includes:

    • Acceptance Criteria and Reported Device Performance (for the dental cement): This is presented in the tables under "9. Performance Bench Tests" for G-CEM ONE and "G-CEM ONE ADHESIVE ENHANCING PRIMER" on pages 4 and 5. These criteria relate to properties like film thickness, working time, setting time, flexural strength, water sorption, solubility, radiopacity, appearance, coatability, color tone, and refractive index.
    • Sample Size for Test Set and Data Provenance: Not specified for any AI/ML context. The performance tests are laboratory bench tests, not clinical studies with human subjects.
    • Number of Experts and Qualifications: Not applicable as it's not an AI/ML device requiring expert ground truth for interpretation.
    • Adjudication Method: Not applicable.
    • Multi Reader Multi Case (MRMC) Comparative Effectiveness Study: Not mentioned as it's not an AI/ML device.
    • Standalone Performance: Not applicable for an AI/ML device.
    • Type of Ground Truth Used: Not applicable for an AI/ML device.
    • Sample Size for Training Set & How Ground Truth for Training Set Was Established: Not applicable as it's not an AI/ML device.

    Please provide a document related to an AI/ML device if you wish for me to extract information on its acceptance criteria and study data.

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