LogoFDA 510(k) Search
Search Filters

Search Results

Found 1 results

510(k) Data Aggregation

    K Number
    K253461
    Device Name
    Demi Pro
    Manufacturer
    Meta Systems Co., Ltd.
    Date Cleared
    2025-10-14

    (7 days)

    Product Code
    EBZ
    Regulation Number
    872.6070
    Type
    Traditional
    Panel
    Dental
    Reference & Predicate Devices
    K220471,K170529
    Predicate For
    N/A
    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
    Intended Use

    The Demi Pro is an LED visible light curing unit intended for polymerization of light-cured materials by dental professionals. It is also intended to provide illumination to aid in visualization during oral procedures.

    Device Description

    The Demi Pro is a pen-style cordless curing light used for the polymerization of light cured dental material and is powered by a rechargeable lithium-ion battery pack. An intraoral transillumination tip is available as an additional accessory. It is also intended to provide illumination to aid in visualization during oral procedures.
    The LED Light Curing System operates by emitting high-intensity blue light from a powerful LED to activate the photo initiators contained in the resin, thereby initiating polymerization (curing).
    Wavelength range:

    • Usable wavelength range: 380 nm – 515 nm
    • Peak wavelengths: 400 nm, 460 nm
      Light intensity levels:
    • PLS STD: 1100 -1330 mW/cm²
    • PLS HIGH: 2200 – 2500 mW/cm²
    • ORTHO: 2500 mW/cm²
    • DIAGNOSIS: 20 – 24 mW
      Duty cycle:
    • PLS STD: 20 sec ON / 60 sec OFF
    • PLS HIGH: 5 sec ON / 60 sec OFF
    • ORTHO: 3 sec x 3 times ON / 60 sec OFF
    • DIAGNOSIS: 60 sec ON / 60 sec OFF
      Waterproof rating: IPX4 (Applies to Handpiece)
    AI/ML Overview

    N/A

    Ask a Question

    Ask a specific question about this device

    Page 1 of 1