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510(k) Data Aggregation

    K Number
    K232952
    Device Name
    Copran Zri
    Manufacturer
    Whitepeaks Dental Solutions GmbH
    Date Cleared
    2024-06-24

    (277 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K092496,K051705
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Copran Zri consists of machinable zirconia discs for the preparation of full ceramic crowns, onlays and 3-and 4-unit bridges and inlay bridges (anterior and molar.)

    Device Description

    Pre-sintered zirconia blanks for the fabrication of individual dental restorations.

    Copran Zri disks come in both white and pre-shaded light, medium or intense in 95 and 98 mm diameter in thicknesses from 10-25mm.

    AI/ML Overview

    This is a 510(k) premarket notification for a medical device called "Copran Zri," which consists of machinable zirconia discs for dental restorations. The document asserts that this device is substantially equivalent to a predicate device, Ivoclar IPS e.max ZirCad MO (K051705), and references Whitepeaks Copran Zr (K092496).

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

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

    The document implicitly uses the performance of the predicate and reference devices, as well as standards like ISO 6872:2015, to establish acceptance criteria. The table below compiles the reported device performance for Copran Zri in comparison to these.

    Acceptance Criteria (from ISO 6872:2015 and Predicate/Reference)Copran Zri PerformanceNotes
    Physical Properties
    ISO 6872:2015 ClassificationType II Class 5Copran Zri, Copran Zri Light, Medium and Intense all meet this classification, which is consistent with the reference and predicate devices. This standard dictates properties for ceramic materials for dental restorations.
    Bending/Flexural Strength (MPa)1400Reported as 1400 MPa for Copran Zri. The predicate device (Ivoclar ZirCad MO) has 1150 MPa, and the reference device (Copran Zr) has 1400 MPa. Copran Zri meets or exceeds the predicate.
    Fracture Toughness (MPa·m1/2)5Reported as 5 MPa·m1/2 for Copran Zri. The predicate device has >5.1 MPa·m1/2, and the reference device has 5 MPa·m1/2. Copran Zri is comparable to the reference and close to the predicate.
    Solubility (µg/cm²)6.7Reported as 6.7 µg/cm² for Copran Zri. The predicate device has
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