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510(k) Data Aggregation

    K Number
    K160367
    Device Name
    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
    Manufacturer
    Nissin-Metec China Co., Ltd.
    Date Cleared
    2016-07-27

    (169 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K141724
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nissin-Metec China Co., Ltd.

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

    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank are indicated for the production of artificial teeth in fixed or removable dentures, or for jacket crowns, facings, and veneers.

    Device Description

    Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blanks are available in various specifications, which are combinations of different dimensions and shapes (Semics, Rods, Blocks and Discs). Furthermore, each specification is available in twenty two (22) color configurations.

    AI/ML Overview

    This document describes the premarket notification (510(k)) for the "Nissin Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank." The submission aims to demonstrate substantial equivalence to a predicate device.

    Here's an analysis of the provided information regarding acceptance criteria and the study that proves the device meets them:

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are established primarily through conformity to ISO 6872:2008 (Dentistry - Ceramic materials) and ISO 10993 series for biocompatibility. The reported device performance is presented in "Table 1 Results of Non-clinical Tests" and compared against the predicate device in "Table 2 Comparison of Technology Characteristics."

    ItemAcceptance Criteria (typically based on ISO 6872 or ISO 10993 standards)Reported Device Performance (Nissin Dental Zirconia Blank)
    RadioactivityConforms to ISO 6872 (Predicate:
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