LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K250025
    Device Name
    Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )
    Manufacturer
    Aidite (Qinhuangdao) Technology Co., Ltd.
    Date Cleared
    2025-03-14

    (67 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K232676
    Why did this record match?
    Device Name :

    Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid )

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

    Porcelain Powder can be used to make facings and veneers of customized denture crowns. It is suitable for adults over 18 years old.

    Device Description

    This product includes Porcelain Powder, Stain/Glaze, Stain/Glaze-A and Modeling Fluid.

    Enamel/ Modifier is Enamel porcelain, its function is to make adjusted porcelain powder gently stacked in the incisal aimed at shape, and stack from incisal to the body, covering dentin porcelain:

    Stain/Glaze and Stain/Glaze-A is Enamel layer, its function is to coat with a thin layer of glaze on the surface of the finishing porcelain crown to achieve the required color and gloss of natural teeth.

    Modeling Fluid: A dental ceramic powder is mixed in order to shape or model it into its required form prior to firing

    AI/ML Overview

    The provided text is an FDA 510(k) summary for a dental product, "Porcelain Powder." It outlines the product's classification, intended use, and a comparison to a predicate device to establish substantial equivalence.

    Crucially, this document is for a dental material (Porcelain Powder), not a medical device software (MDSW) or an AI/ML-driven device. Therefore, the information requested in your prompt regarding acceptance criteria, study details, ground truth, expert adjudication, MRMC studies, and standalone performance for AI/ML devices is not present in this regulatory submission.

    The document states: "Clinical testing was not required for this submission." This indicates that no human performance or comparative effectiveness studies were conducted for this traditional material device. The "Non-clinical Test Conclusion" section primarily refers to bench testing for physical and mechanical properties, and biocompatibility testing.

    To answer your prompt with the provided input, I must state that the requested information (acceptance criteria, study details for AI/ML device performance) is not applicable to the Porcelain Powder device and is not contained within this 510(k) summary.

    Therefore, I cannot populate the table or provide the requested details about acceptance criteria, study design, ground truth, or expert involvement as this information pertains to a different type of medical device (AI/ML or diagnostic software) than the "Porcelain Powder" described in the provided text.

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1