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510(k) Data Aggregation

    K Number
    K223706
    Device Name
    PMMA BLOCK
    Manufacturer
    Huliang(shanghai) Bio-Tech Co., Ltd.
    Date Cleared
    2023-05-12

    (151 days)

    Product Code
    EBG,EBI,MQC
    Regulation Number
    872.3770
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K201683
    Why did this record match?
    Applicant Name (Manufacturer) :

    Huliang(shanghai) Bio-Tech Co., Ltd.

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

    PMMA BLOCK is used for the fabrication removable or temporary dental structures, such as crowns and bridges using milling technology using CAD/CAM.

    Indications for Use:

    • Temporary anterior and posterior crowns;
    • Temporary anterior and posterior bridges;
    • Removable structures for dentures;
    • Removable structures for therapeutic restorations (night guards, bite splints or occlusal splints).
    Device Description

    PMMA BLOCK is a circular solid (disc) or rectangular solid (block) of PMMA with or without post attachment for use in a CAD/CAM milling machine for production of provisional restorative prostheses such as dental crowns and bridges and removable dental structures. These blocks are available in a variety of shapes for different milling systems and are also available in variety of dental shades.

    AI/ML Overview

    The provided text is a 510(k) Summary for a medical device called "PMMA BLOCK." This document describes the device, its intended use, and compares it to a predicate device to demonstrate substantial equivalence, primarily focusing on physical and chemical properties and biocompatibility.

    Here's an analysis of the provided information concerning acceptance criteria and supporting studies:

    1. A table of acceptance criteria and the reported device performance:
    Acceptance Criteria (ISO Standard)Requirement for Subject Device (PMMA BLOCK)Reported Performance (Subject Device)Reported Performance (Predicate Device K201683)
    Flexural Strength
    ISO 10477$\geq$ 50 MPa$\geq$ 50 MPa$\geq$ 50 MPa
    ISO 20795-1$\geq$ 65 MPa$\geq$ 65 MPa$\geq$ 65 MPa
    Water Absorption
    ISO 10477$\leq$ 0.040 mg/mm³$\leq$ 0.040 mg/mm³$\leq$ 0.040 mg/mm³
    ISO 20795-1$\leq$ 0.032 mg/mm³$\leq$ 0.032 mg/mm³$\leq$ 0.032 mg/mm³
    Water Solubility
    ISO 10477$\leq$ 0.0075 mg/mm³$\leq$ 0.0075 mg/mm³$\leq$ 0.0075 mg/mm³
    ISO 20795-1$\leq$ 0.0016 mg/mm³$\leq$ 0.0016 mg/mm³$\leq$ 0.0016 mg/mm³
    Residual Monomer ContentISO 20795-1: $\leq$ 2.2%$
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