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510(k) Data Aggregation

    K Number
    K042348
    Device Name
    GRADIA DIRECT LOFLO
    Manufacturer
    GC AMERICA, INC.
    Date Cleared
    2004-11-18

    (80 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    N/A
    Why did this record match?
    Device Name :

    GRADIA DIRECT LOFLO

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    This product is a light-cured fluoride releasing microfilled hybrid composite restorative resin. Recommended Indications: 1. Restoration of Class I, II, III, IV, V cavities (particularly for small Class I cavities/ shallow Class V cavities/ other small cavities). 2. Restoration of root surface caries. 3. Restorations in deciduous teeth. 4. Filling tunnel shaped cavities. 5. Sealing hypersensitive areas. 6. Liner/base/filling in cavity undercuts. 7. Sealant. 8. Fixation of mobile teeth. 9. Additions to composite restorations.

    Device Description

    Not Found

    AI/ML Overview

    This document is a 510(k) clearance letter from the FDA for a dental restorative material, not a study report detailing acceptance criteria and performance data for a device involving AI or complex statistical analysis.

    Therefore, the requested information elements (1 through 9) related to a study proving device meeting acceptance criteria, especially those pertinent to AI/software performance, are not present in this document.

    Specifically, there is no information regarding:

    1. A table of acceptance criteria and the reported device performance: This letter indicates substantial equivalence to a predicate device, not a performance study against specific acceptance criteria.
    2. Sample size used for the test set and the data provenance: No test set is described.
    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable.
    4. Adjudication method for the test set: Not applicable.
    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done: Not applicable, as this is a dental material, not an AI-assisted diagnostic device.
    6. If a standalone performance (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
    7. The type of ground truth used: Not applicable.
    8. The sample size for the training set: Not applicable.
    9. How the ground truth for the training set was established: Not applicable.

    This document serves as an FDA clearance for a dental material (Gradia® Direct LoFlo) based on its substantial equivalence to previously marketed predicate devices, not on a new clinical performance study with detailed acceptance criteria and statistical analysis as would be relevant for devices with diagnostic or AI components.

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