LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K242277
    Device Name
    Crown HT
    Manufacturer
    SprintRay Inc.
    Date Cleared
    2024-10-01

    (61 days)

    Product Code
    EBF,EBG,EBI,ELM,PZY
    Regulation Number
    872.3690
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K222623
    Why did this record match?
    Device Name :

    Crown HT

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

    SprintRay Crown HT is a light-curable polymerizable resin intended to be used for the fabrication of; individual and fixed definitive full single crowns; definitive partial crowns in anterior and posterior area, individual and fixed single veneers; artificial teeth for dental prostheses, which are used for removable definitive full dentures; and individual and removable monolithic full and partial dentures in dental offices and laboratories. The material is an alternative to traditional restorative dental material.

    Device Description

    SprintRay Crown HT is a photo-polymer methacrylate resin material used in conjunction with a 3D printer and a scanned 3D image in a dental office to build dental prosthetics by 3D printing layer upon layer of the composite material. SprintRay Crown HT resin is offered in various shades such as Bleach. A1, A2, A3, and B1. Crown HT is an alternative to traditional dental prosthesis material that is intended exclusively for professional dental work.

    SprintRay Crown HT resin is intended exclusively for professional dental work. Fabrication of dental prosthetics with SprintRay Crown HT resin requires computer-aided design and CAD/CAM manufacturing system that includes the following components not part of the device: Crown HT file created in an optical impression system, 3D printer, and curing light equipment.

    Crown HT resin is designed to meet appropriate ISO standards for flexibility and sorption, to withstand prolonged use in the oral cavity. It is delivered non-sterile, and instructions on curing, and cleaning the final device prior to providing it to a patient are provided in the device instruction for use (IFU) document.

    AI/ML Overview

    The provided text describes the 510(k) summary for SprintRay Inc.'s "Crown HT" dental resin. It includes acceptance criteria for the device based on performance testing but does not describe a study involving human readers, ground truth consensus, or AI assistance for diagnostic purposes. The device being discussed is a material for fabricating dental prosthetics, not a diagnostic imaging AI system.

    Therefore, many of the requested elements (e.g., sample size for test set, number of experts for ground truth, MRMC study, effect size of human reader improvement with AI, type of ground truth for AI, training set size for AI, ground truth establishment for AI training) are not applicable to this submission.

    However, I can extract the relevant acceptance criteria and performance data for the material properties of the Crown HT resin, as well as information about the studies conducted to prove these properties.

    Here's the information based on the provided text:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are generally implied by the requirement to perform testing based on ISO standards and to show comparable or better performance than the predicate device.

    Acceptance Criteria (from Predicate/ISO Standards)Reported Crown HT Device Performance
    Material Properties:
    Flexural Strength (>50.0 MPa)>124 MPa
    Flexural Modulus>7000 MPa
    Sorption (
    Ask a Question

    Ask a specific question about this device

    Page 1 of 1