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510(k) Data Aggregation

    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
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K141562,K180657
    Why did this record match?
    Reference Devices :

    K141562

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

    AI/ML Overview

    The provided text is a 510(k) summary for a dental device called "GC Temp PRINT". This document primarily focuses on establishing substantial equivalence to predicate devices, rather than describing a study proving the device meets specific acceptance criteria in the context of AI/ML performance.

    Therefore, the requested information regarding acceptance criteria and performance study for AI/ML aspects cannot be fully provided from the given document as it refers to material properties and biocompatibility, not AI/ML performance.

    However, I can extract the acceptance criteria and the bench test results for the physical properties of the GC Temp PRINT device as described in Section 6, "Performance Bench Tests".

    1. Table of Acceptance Criteria and Reported Device Performance

    PropertyStandardsAcceptance Criteria (Requirements in ISO 10477:2018 and/or Company specification)Reported Device Performance (Implied "Compliance")
    Depth of cureCompany specification (1AB-1500-3-10696(3))0.098 – 0.130 mmComplies
    Flexural strengthISO 10477: 2018 5.4 Flexural strength (Fabricated by 3D Printer)> 50 MPaComplies
    Water sorptionISO 10477: 2018 5.6 Water sorption (Fabricated by 3D Printer)
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