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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
    Reference & Predicate Devices
    K141562,K180657
    Predicate For
    N/A
    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)< 40 µg/mm³Complies
    SolubilityISO 10477: 2018 5.7 solubility (Fabricated by 3D Printer)< 7.5 µg/mm³Complies

    Regarding the AI/ML-specific questions (2-9), the provided document does not contain this information as it describes a physical material, not an AI/ML device.

    Here's why each AI/ML question cannot be answered:

    • 2. Sample size used for the test set and the data provenance: Not an AI/ML device.
    • 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable for material property testing.
    • 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for material property testing.
    • 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not an AI/ML device.
    • 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not an AI/ML device.
    • 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): The ground truth for material properties is defined by established international standards (ISO) and company specifications, measured objectively.
    • 8. The sample size for the training set: Not an AI/ML device, so no training set.
    • 9. How the ground truth for the training set was established: Not an AI/ML device, so no training set with ground truth.
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