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510(k) Data Aggregation

    K Number
    K211489
    Device Name
    Dental Impression Material
    Manufacturer
    Nanchang Dental Bright Technology Co., Ltd
    Date Cleared
    2021-07-28

    (76 days)

    Product Code
    ELW
    Regulation Number
    872.3660
    Type
    Traditional
    Panel
    Dental Devices (DE)
    Reference & Predicate Devices
    K201483
    Why did this record match?
    Applicant Name (Manufacturer) :

    Nanchang Dental Bright Technology Co., Ltd

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

    The Dental Impression Material is intended for use with all crowns, bridges, and orthodontic impression techniques to reproduce the structure of a patient's teeth and gums.

    Device Description

    The Dental Impression Material is a kind of addition-cure rubber impression material composed of vinyl polysiloxane and various fillers, with neutral smell and applicable to impression in dentistry. The Dental Impression Material is very easy to mix and has good dimensional stability, helps to make precise impression taking.

    AI/ML Overview

    The provided document describes the acceptance criteria and a study for the Nanchang Dental Bright Technology Co., Ltd's Dental Impression Material.

    1. Table of Acceptance Criteria and Reported Device Performance:

    ItemAcceptance Criteria (Type 0)Reported Device PerformanceResult
    Consistency
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