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    K Number
    K141788
    Device Name
    OBSIDIAN MILLING BLOCKS
    Manufacturer
    PRISMATIK DENTALCRAFT, INC.
    Date Cleared
    2014-08-20

    (49 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K100781
    Why did this record match?
    Device Name :

    OBSIDIAN MILLING BLOCKS

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

    The Obsidian™ Milling Blocks is used to fabricate ceramic dental prostheses in the nature of crowns and bridges for posterior and anterior applications using CAD/CAM methods.

    Device Description

    The Obsidian™ Milling Blocks are a lithium silicate ceramic to be supplied with or without an attached mandrel to be milled using CAD/CAM methods. The product can produce a variety of monolithic restorations with great esthetics, lifelike translucency, and high strength including full-contour crowns, inlays, onlays, veneers partial crowns and substructures due to its excellent machining properties. The milling blocks will be available in the commonly used VITA Classical and Chromascop Bleach shades.

    AI/ML Overview

    Here's a breakdown of the acceptance criteria and study information for the Obsidian™ Milling Blocks, based on the provided text:

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

    Acceptance Criteria (Predicate)Reported Device Performance (Proposed Device)Substantial Equivalence
    Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM or hot-press methods.Indications for Use: Fabricate ceramic dental prostheses (crowns and bridges) for posterior and anterior applications using CAD/CAM methods.Same (Proposed explicitly states CAD/CAM, but overall use is consistent)
    Composition: Provided in Section 011 (though not detailed in the comparison table)Composition: Provided in Section 011. Additional materials were added (details in section 011).Difference (Additional materials were added, but deemed not to introduce new safety/effectiveness issues)
    Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, C3, D2, D3, BL1, BL4Shades: A1, A2, A3, A35, B1, B2, B3, C1, C2, D2, D3, BL1, BL4Same
    Flexural Strength: >300 MPa (meeting ISO 6872 requirements)Flexural Strength: >300 MPa (meeting ISO 6872 requirements)Same
    Chemical Solubility:
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