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510(k) Data Aggregation

    K Number
    K183569
    Device Name
    DD cube ONE ML
    Manufacturer
    Dental Direkt GmbH
    Date Cleared
    2019-02-14

    (55 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Special
    Panel
    Dental
    Reference & Predicate Devices
    K170885
    Why did this record match?
    Device Name :

    DD cube ONE ML

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

    DD cube ONE ML dental zirconia blanks are indicated for crowns, multi-unit bridges and inlay bridges. Applications include both, anterior and posterior bridges.

    Device Description

    DD cube ONE ML are dental milling blanks made of yttria-stabilized pre-sintered zirconium dioxide, showing a super high translucency and a high strength and fracture toughness at the same time. The ceramics are of type II (not powder), Class 5 according to DIN EN ISO 6872 (FDA Recognition Number 4-223). The material is suited ideally for crowns and bridges for both, the anterior and posterior region.

    AI/ML Overview

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

    Device: DD cube ONE ML (Dental Zirconia Blanks)
    Predicate Device: K170885: Dental Direkt GmbH DD cube ONE (former DD cubeX2 HS)

    1. Table of Acceptance Criteria and Reported Device Performance

    Acceptance Criteria (Requirement from ISO 6872:2015)Required ValueAchieved ValuePassed / Failed
    Uniformity (Clause 5.1)N/A (Visual Inspection)-Passed
    Freedom from extraneous materials (Clause 5.2.1)N/A (Visual Inspection)-Passed
    Activity concentration of uranium 238 (Clause 5.2.2)
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