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510(k) Data Aggregation

    K Number
    K151846
    Device Name
    Rainbow LS Pressing
    Manufacturer
    GENOSS
    Date Cleared
    2016-01-14

    (191 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K120134
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    rainbow™ LS Pressing is used in the manufacture of Inlay, Onlay and Crown.

    Device Description

    rainbow™ LS Pressing is a lithium disilicate glass-ceramic ingot for use with the press technique with similar strength and esthetics to natural tooth.

    AI/ML Overview

    The provided document is a 510(k) Summary for a dental ceramic device, "rainbow™ LS Pressing." It outlines the device's characteristics and its substantial equivalence to a predicate device, IPS e.max Press and IPS e.max Press Multi. The document describes several non-clinical tests conducted to confirm the device's performance against established standards.

    Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

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

    Acceptance Criteria (Standard)Predicate Device Performance (IPS e.max Press and IPS e.max Press Multi)Subject Device Performance (rainbow™ LS Pressing)Comparison/Conclusion
    Bending Strength (ISO 6872:2008 for Class 3 dental ceramics: > 300 MPa)400 Mpa569 MPaSubject device is higher than both predicate and required standard.
    **Chemical Solubility (ISO 6872:2008 for Class 2 or 3 dental ceramics:
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