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510(k) Data Aggregation

    K Number
    K230098
    Device Name
    Trusana™
    Manufacturer
    Myerson, LLC
    Date Cleared
    2023-04-13

    (90 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K191497
    Why did this record match?
    Reference Devices :

    K191497

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

    Trusana™ resin is intended to 3D print denture base for use in making removable full and partial dentures or overdentures. Trusana™ is intended exclusively for professional dental work. Fabrication of denture bases with Trusana™ requires a computer-aided and manufacturing (CAD/CAM) system using the Asiga MAX UV or Asiga PRO 4K 3D printer in conjunction with the Asiga Flash curing chamber.

    Device Description

    The Trusana device is a light-activated denture base resin, offered in four shades.
    The Trusana resin is used with patient-specific *.stl files provided by the dental practitioner to fabricate the customized denture bases for removable denture devices using a 3D (additive) printer and curing unit.
    The proprietary light-curable resin is composed of methylacrylated monomers, methacrylated carboxylic acid, phosphine oxide initiator and pigments for color
    It is used by dental laboratories and dental practices to make the denture bases for the removable dentures.
    The resin is offered in lightproof 1L high density polyethylene (HDPE) bottles.
    Trusana resin is an alternative material to heat-curable and auto-polymerizable resins.

    AI/ML Overview

    The provided text describes the 510(k) premarket notification for Trusana™, a light-activated denture base resin. It includes acceptance criteria and performance data for the device, but it does not describe studies proving device performance with AI assistance, MRMC studies, or multi-reader studies establishing ground truth by medical experts. The context is a material science and manufacturing regulatory submission, not an AI/software medical device submission.

    Therefore, many of the requested details, particularly those related to AI, human readers, ground truth establishment by medical experts, and training/test set sample sizes for AI models, are not present in the provided document.

    Here's an analysis of the information that is available in relation to your request:

    1. A table of acceptance criteria and the reported device performance

    The document provides a comparison table between the new device (Trusana™) and the primary predicate device (NextDent Denture 3D+), with specific performance characteristics based on ISO 20795-1.

    Acceptance Criteria and Device Performance (for Trusana™ vs. Predicate)

    CharacteristicAcceptance Criteria (Trusana™ - based on "or more/less" relative to ISO standard)Reported Performance (Trusana™)Predicate Performance (NextDent Denture 3D+)ISO Standard Reference (Implicit Acceptance Metric)
    Cured Product Characteristics:
    SterilityNon-sterileNon-sterileNon-sterileN/A
    Ultimate Flexural Strength65 MPa or more (per ISO 20795-1)(Performance implicitly met as it is cleared)84 MPa (per ISO 20795-1)ISO 20795-1
    Flexural (Bending) Modulus2000 MPa or more (per ISO 20795-1)(Performance implicitly met as it is cleared)2383 MPa (per ISO 20795-1)ISO 20795-1
    Water Sorption32 µg/mm3 or less (per ISO 20795-1)(Performance implicitly met as it is cleared)28 µg/mm3 (per ISO 20795-1)ISO 20795-1
    Water Solubility1.6 µg/mm3 or less (per ISO 20795-1)(Performance implicitly met as it is cleared)0.1 % (w/w) (per ISO 20795-1)ISO 20795-1
    Residual monomer0% (per ISO 20795-1)(Performance implicitly met as it is cleared)
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