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510(k) Data Aggregation

    K Number
    K191591
    Device Name
    BB Base 3D printing resin for denture base
    Manufacturer
    Enlighten Materials Co., Ltd
    Date Cleared
    2020-08-18

    (431 days)

    Product Code
    EBI
    Regulation Number
    872.3760
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K162044
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    BB Base 3D printing resin for denture base, developed by ENLIGHTEN MATERIALS Co., Ltd., is a light-cured resin indicated for the fabrication of full removable denture bases in dental laboratories. It is an alternative to traditional heat-cured, light-cured or light-cured denture base resins. BB Base 3D printing resin for denture base should be used exclusively by dental professionals. Fabrication of denture bases with BB Base 3D printing resin for denture base requires a computer-aided and manufacturing (CAD/CAM) system including the following; optical impression system, design software (CAD software), stereolithographic additive printer, and post-cure unit.

    Device Description

    BB Base is a photosensitive resin intended to fabricate removable dentures in a CAD/CAM additive printing process. The BB Base 3D printing resin for denture base is a viscous solution of the following compounds: methacrylate-based resins, a photoinitiator that activates between 385nm to 405 nm light, and pigments. It comes in one size, one kilogram per bottle. It is a Type 4 (light-activated) acrylic resin as classified ISO20795-1. The material is used in a 3D printer, which prints the shape determined by a 3D stereolithographic drawing. After printing, the printed product is placed in a UV-light curing box for final polymerization. 3D printer is not included with the device.

    AI/ML Overview

    Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:

    Device Name: BB Base 3D printing resin for denture base
    Predicate Device: Dentca Denture Base II (K162044)

    1. Table of Acceptance Criteria and Reported Device Performance

    The acceptance criteria are largely based on the ISO 20795-1 standard for "Dentistry - Base polymers - Part 1: Denture base polymers" and comparisons to the predicate device.

    Performance MetricAcceptance Criteria (ISO 20795-1 where applicable)Reported Device Performance (BB Base)Comparison to Predicate (Dentca Denture Base II)
    Material Properties
    Flexural Strength> 65 MPa (Predicate's value, implied as threshold)> 85.2 MPaMet the criteria of ISO 20975-1
    Flexural Modulus> 2000 MPa (Predicate's value, implied as threshold)> 2049 MPaMet the criteria of ISO 20975-1
    Viscosity1000
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