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510(k) Data Aggregation

    K Number
    K191836
    Device Name
    Ceramill A-Splint
    Manufacturer
    Amann Girrbach AG
    Date Cleared
    2019-12-20

    (164 days)

    Product Code
    MQC
    Regulation Number
    N/A
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K134015
    Why did this record match?
    Device Name :

    Ceramill A-Splint

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

    Ceramill A-Splint is indicated for the fabrication of removable bite splints.

    Device Description

    Ceramill A-Splint are ready to use, polymethyl methacrylate (PMMA) based computer-aided design/computer-aided manufacturing (CAD-CAM) blanks, for milling splints. Ceramill A-Splint is available as a disk (round form) or as an arch-form (or "U"-shape).

    AI/ML Overview

    This document, concerning the Ceramill A-Splint, primarily details a substantial equivalence determination by the FDA for a medical device and does not describe the acceptance criteria and a study proving a device meets them in the context of an AI/algorithmic device. There is no mention of AI, machine learning, or software performance in this document.

    Therefore, I cannot provide the requested information regarding acceptance criteria and a study proving device performance using AI or algorithmic methods from the provided text.

    The closest information available that might relate to "acceptance criteria" for this device, which is a physical material for dental applications, are the bench performance testing results compared against the ISO 20795-2:2013 standard.

    Here's a breakdown of what can be extracted, interpreting "acceptance criteria" as the performance requirements from the referenced international standard for the physical materials:

    1. Table of Acceptance Criteria and Reported Device Performance

    Performance AttributeAcceptance Criteria (from ISO 20795-2:2013)Ceramill A-Splint PerformancePredicate Device (M-PM-Disc) PerformanceComparison to Predicate / Acceptance
    Residual Monomer100 MPa91.5 MPa - 96.6 MPaSimilar; meets ISO 20795-2:2013 (≥50)
    Water Solubility≤ 5 µg/mm³
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