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510(k) Data Aggregation

    K Number
    K182350
    Device Name
    Dental Ceramic
    Manufacturer
    Baot Biological Technology Co., LTD
    Date Cleared
    2019-05-22

    (266 days)

    Product Code
    EIH
    Regulation Number
    872.6660
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K140848
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    Dental Ceramic is indicated for use for metal-ceramic full veneers and for zirconia full veneers and partial veneers.

    Device Description

    Dental Ceramic divided into two categories: Metal Ceramic; Zirconia Ceramic. They are used to be made for simulation tooth of human whose ages above 18. After fired, form the whole or part of a dental restoration or prosthesis. It is made by Aluminium oxide(Al2O3), Silicon dioxide (SiO2), Potassium carbonate (K2CO3), Sodium carbonate (Na2CO3), Calcium oxide (CaO), Zirconium dioxide (ZrO2).

    Metal Ceramic: a complete metallic substructure of Dental Ceramic are Glaze separated two parts-metal and ceramic, which is made of metal alloys and whose inner is a framework. The materials within the metallic is broadly divided into three categories: precious metal, semiprecious metal alloys and non-precious metal alloys, being usually called inner alloy crown.

    Zirconia Ceramic: A complete Zirconia Ceramics are separated two parts-Zirconia coping and porcelain layer (Dentin layer and Enamel layer), as shown in the figure, the innermost layer of dental ceramic is Zirconia coping which is a framework. It has a positive impact on bearing and combining closely with the dentin layer.

    AI/ML Overview

    The provided text describes a 510(k) summary for a dental ceramic device, which does not contain information about an AI/ML powered device. Therefore, a description of acceptance criteria and studies related to AI/ML performance is not applicable. The document focuses on demonstrating substantial equivalence to a predicate device through material composition, mechanical properties (flexural strength, solubility, glass transition temperature), and biocompatibility testing.

    Here's the information extracted from the provided text, structured to align with the prompt's request where applicable for non-AI devices:

    1. Table of Acceptance Criteria and Reported Device Performance

    FeatureAcceptance Criteria (from ISO 6872)Reported Device Performance
    Metal Ceramic
    Opaque Flexural StrengthMet ISO 6872 requirements98.63 MPa
    Dentine Flexural StrengthMet ISO 6872 requirements98.07 MPa
    Enamel Flexural StrengthMet ISO 6872 requirements102.48 MPa
    Opaque SolubilityMet ISO 6872 requirements15.88 µg.cm-2
    Dentine SolubilityMet ISO 6872 requirements36.77 µg.cm-2
    Enamel SolubilityMet ISO 6872 requirements18.40 µg.cm-2
    Opaque Glass Transition Temp.Met ISO 6872 requirements575°C
    Dentine Glass Transition Temp.Met ISO 6872 requirements575°C
    Enamel Glass Transition Temp.Met ISO 6872 requirements575°C
    Zirconia Ceramic
    Dentine Flexural StrengthMet ISO 6872 requirements92.56 MPa
    Enamel Flexural StrengthMet ISO 6872 requirements98.87 MPa
    Dentine SolubilityMet ISO 6872 requirements18.17 µg.cm-2
    Enamel SolubilityMet ISO 6872 requirements28.60 µg.cm-2
    Dentine Glass Transition Temp.Met ISO 6872 requirements590°C
    Enamel Glass Transition Temp.Met ISO 6872 requirements590°C
    BiocompatibilityMet ISO 10993-1, -3, -5, -10, -11, USP40 requirementsMet the requirements of ISO 10993-1, -3, -5, -10, -11, USP40

    2. Sample size used for the test set and the data provenance:

    • Test set sample size: Not explicitly stated for performance testing (mechanical properties) or biocompatibility. The results are presented as single values for each material property type (e.g., flexural strength).
    • Data provenance: Not explicitly stated (e.g., country of origin). The studies appear to be laboratory-based material characterization studies conducted by the manufacturer or a contracted lab.

    3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This device is not an AI/ML product where expert consensus for ground truth is typically required. The ground truth for material properties is established by recognized international standards (ISO 6872 and ISO 10993).

    4. Adjudication method for the test set: Not applicable. This device does not involve subjective assessment requiring adjudication.

    5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a dental ceramic material, not an AI/ML diagnostic or assistive tool.

    6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.

    7. The type of ground truth used:

    • Mechanical Performance: Ground truth is established by the requirements and methodologies defined in ISO 6872:2008 (and comparison to ISO 6872:2015) for Dentistry - Ceramic materials.
    • Biocompatibility: Ground truth is established by the requirements and methodologies defined in ISO 10993 series and USP40 for biological evaluation of medical devices.

    8. The sample size for the training set: Not applicable. This device is a material, not an AI/ML model that requires a training set.

    9. How the ground truth for the training set was established: Not applicable.

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