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510(k) Data Aggregation

    K Number
    K102538
    Device Name
    ZIECON DISC WITH COLLAR FOR CAD/CAM MODEL ZD810-26, ZIECON BLOCK FOR MOM MODEL ZB763812-20, ZB653012-21, ZB402012-20, ZI
    Manufacturer
    JYOTI CERAMIC INDUSTRIES PRIVATE LIMITED
    Date Cleared
    2010-10-27

    (54 days)

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

    ZIECON® Zirconia Ceramic Blanks are designed for manufacturing ceramic dental restorations such as single crowns or bridgeworks. The ceramic dental blank is machined by the customers/dental laboratories on their milling centers or similar equipment using CAD/CAM techniques & MOM for design and processing to the patient-specific anterior/posterior tooth/bridge specification provided by the dental practitioner.

    Device Description

    ZIECON® Zirconia Ceramic Dental Blanks

    AI/ML Overview

    This document is a marketing approval letter from the FDA for a dental device, specifically "ZIECON® Zirconia Ceramic Dental Blanks". It does not contain any information about acceptance criteria, device performance studies, or AI/software algorithms.

    Therefore, I cannot provide a response to your request as the input document does not contain the necessary information.

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