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510(k) Data Aggregation

    K Number
    K191843
    Device Name
    Ceramill A-Temp
    Manufacturer
    Amann Girrbach AG
    Date Cleared
    2019-10-04

    (87 days)

    Product Code
    EBG,POW
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K112967
    Why did this record match?
    Device Name :

    Ceramill A-Temp

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use
    • Temporary anterior and posterior crowns with a wearing time of maximum three years
    • Temporary anterior and posterior bridges with a maximum of two connected pontics and a maximum wearing time of three years
    • Verifying the fit on the plaster model/mouth before the final restoration
    Device Description

    Ceramill A-Temp are ready to use, polymethyl methacrylate (PMMA) based computeraided manufacturing (CADCAM) blanks, for milling long-term temporary crowns and bridges and for verifying the fit on the plaster model/mouth before the final restoration is manufactured.

    Ceramill A-Temp is available as a disk (round form) or as an arch-form (or "U"-shape) disk or as block shape blanks.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Ceramill A-Temp device, based on the provided FDA 510(k) summary:

    Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Standard / Requirement)Ceramill A-Temp PerformanceComparison to Predicate Device
    Residual monomer (ISO 10477:2018 requirement: 135 MPaSimilar to predicate (≥ 114 MPa); both exceed requirement.
    Water solubility (ISO 10477:2018 requirement: ≤ 7.5 µg/mm³)
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