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510(k) Data Aggregation

    K Number
    K203000
    Device Name
    KeyPrint KeySplint Hard
    Manufacturer
    Mycone Dental Supply Co. Inc. (DBA Keystone Industries)
    Date Cleared
    2021-04-09

    (190 days)

    Product Code
    MQC,EBI,KMY
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K062828,K183598,K190107
    Why did this record match?
    Device Name :

    KeyPrint KeySplint Hard

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

    The KeyPrint® KeySplint Hard™ device is indicated for the fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners and retainers.

    Device Description

    KeyPrint® KeySplint Hard™ material is a UV-curable methacrylate-based resin, intended to be used by trained dental professionals for the 3D printing of various biocompatible dental devices such as mouthguards, splints, repositioners, and retainers. The printing of these devices is carried out using DLP printers utilizing pre-specified wavelengths. Each material is indicated for the fabrication of orthodontic and other dental appliances. Each material is recommended for the construction of specific Class I and II dental devices and appliances. In most cases, the devices are 3D printed to create custom devices or appliances.

    AI/ML Overview

    The provided text describes a 510(k) premarket notification for a dental device, KeyPrint® KeySplint Hard™. However, it does not contain information related to a study proving the device meets acceptance criteria for an AI/ML powered device, nor does it detail acceptance criteria for such a device. The document focuses on demonstrating substantial equivalence to predicate devices through physical property testing and biocompatibility for a UV-curable methacrylate-based resin used for 3D printing dental appliances.

    Therefore, I cannot extract the information required by your prompt, as it pertains to AI/ML device testing criteria. The document discusses:

    • Device Name: KeyPrint® KeySplint Hard™
    • Intended Use: Fabrication of orthodontic and dental appliances such as mouthguards, nightguards, splints, repositioners, and retainers.
    • Testing Performed: Physical property testing (flexibility, strength, durability, kinetic interaction with water) and biocompatibility testing.
    • Comparison Method: Demonstrating similar performance to predicate devices (KeyPrint® KeySplint Soft™ and Whip Mix VeriSplint) and meeting ISO and ASTM standardized testing requirements.

    The document does not provide information on:

    • A table of acceptance criteria and reported device performance for an AI/ML powered device.
    • Sample size used for a test set in an AI/ML context.
    • Number of experts or their qualifications for establishing ground truth for an AI/ML test set.
    • Adjudication methods for an AI/ML AI/ML test set.
    • MRMC comparative effectiveness study or related effect size for human readers.
    • Standalone AI algorithm performance.
    • Type of ground truth used (expert consensus, pathology, outcomes data) for AI/ML.
    • Sample size for training set in an AI/ML context.
    • How ground truth for the training set was established for AI/ML.

    The provided text discusses a traditional medical device (resin for 3D printing) and its approval process, not an AI/ML powered device.

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