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510(k) Data Aggregation

    K Number
    K234014
    Device Name
    Obsidian® NOW
    Manufacturer
    Prismatik Dentalcraft, Inc.
    Date Cleared
    2024-02-27

    (70 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K141788
    Why did this record match?
    Device Name :

    Obsidian**®** NOW

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

    Obsidian® NOW is used to fabricate ceramic dental prosthesis in the nature of crowns for posterior and anterior applications using CAD/CAM technology. The block is processed through dental laboratories or by dental professionals.

    Device Description

    Obsidian® NOW is a fully crystallized lithium disilicate glass-ceramic block that can be milled to produce dental restorations using CAD/CAM technology. The block is intended to be used for fabricating monolithic restorations such as full contour crowns without requiring any additional crystallization prior to placement. The milling block is offered in the commonly used VITA® Classical and Chromascop® Bleach shades.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and the study that demonstrates the device meets these criteria, based on the provided text.

    1. Table of Acceptance Criteria and Reported Device Performance:

    Acceptance Criteria (Standard)Reported Device Performance
    Material Properties
    Flexural Strength: ≥300 MPa (ISO 6872:2015/Amd 1:2018, Type II Class 3)Average flexural strength met the acceptance criteria of 300 MPa (Type II, Class 3)
    Chemical Solubility:
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