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510(k) Data Aggregation

    K Number
    K192260
    Device Name
    everX Flow
    Manufacturer
    GC America Inc.
    Date Cleared
    2019-11-22

    (93 days)

    Product Code
    EBF
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K082171,K133182,K153127
    Why did this record match?
    Reference Devices :

    K082171, K133182

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

    everX Flow is a reinforcing dentin replacement material suitable for:

      1. All direct composite restorations including large posterior cavities.
      1. Deep cavities and endo-treated teeth.
      1. Cavities with missing cusps or after amalgam removal and cavities where inlays would also be recommended.
      1. Core build-up
    Device Description

    everX Flow is a light cured, short-fiber-reinforced composite for dentin replacement for the restoration of posterior and anterior teeth. EverX Flow is filled in a syringe. The material is available in two shades, Bulk shade and Dentin shade.

    AI/ML Overview

    The provided document pertains to a 510(k) premarket notification for a dental device named "everX Flow," a tooth shade resin material. This document focuses on demonstrating substantial equivalence to legally marketed predicate devices, primarily through bench testing (performance testing) and biocompatibility assessment, rather than clinical performance testing involving human subjects or AI-assisted diagnostic studies.

    Therefore, many of the requested details regarding acceptance criteria, study methodologies (like sample size for test sets, number of experts, adjudication, MRMC studies, standalone AI performance), and ground truth establishment for a diagnostic AI device are not applicable to this submission. This is a material science and dental product regulatory submission, not a medical AI/software as a medical device (SaMD) submission.

    However, I can extract and present the acceptance criteria and performance data that are relevant to this type of device, which is primarily laboratory bench testing.

    Acceptance Criteria and Reported Device Performance for everX Flow (Dental Resin Material)

    This device, "everX Flow," is a dental restorative material, not an AI or diagnostic device. Therefore, the "acceptance criteria" refer to the physical, chemical, and biological properties of the material itself, as tested in a laboratory setting according to international standards (ISO 4049:2009 and ISO 10993-1:2009 for biocompatibility).

    1. Table of Acceptance Criteria and Reported Device Performance

    PropertyAcceptance Criteria (Requirements per ISO 4049:2009)Reported Device Performance (Compliance)
    Sensitivity to ambient lightRemain physically homogeneousConforms
    Depth of cure (Opaque shade)> 1.0 mmConforms (similar to predicate)
    Depth of cure (Other shade)> 1.5 mmConforms (similar to predicate)
    Flexural strength> 80 MPaConforms
    Water sorption
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