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510(k) Data Aggregation

    K Number
    K232076
    Device Name
    Fibercure
    Manufacturer
    Lumendo AG
    Date Cleared
    2023-11-02

    (112 days)

    Product Code
    QNF
    Regulation Number
    872.6070
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lumendo AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    For light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range.
    Device Description
    Fibercure is a handheld dental curing light intended for light curing polymerization of small areas of dental materials capable of curing in the 385 – 425 nm wavelength range. Fibercure functions by delivering light energy to photocurable dental materials, which utilize the light energy to induce a photopolymerization reaction. Fibercure consists of a pen-shaped handpiece, that is powered with a detachable, rechargeable battery. The handpiece features a user interface containing two push buttons and three status LEDs. The hand-piece is equipped with a solid-state laser diode to generate light energy at a wavelength of 405 ± 5mm and a power of 40 mW. The laser diode is coupled to single-use cure tips containing an optical fiber of 200 µm diameter. The cure tip emits light with an irradiance of 1800 - 2200 mW/cm2 and allows the light to be precisely targeted on the area to be photocured. Fibercure has 2 operation modes to provide either 10 or 20 second irradiation. Fibercure is delivered with a charging stand that is connected to the mains power using a USB power supply. It provides two charging stations and a photometer to confirm the intensity of the emitted light. Fibercure's handpiece is manufactured from anodized aluminum and houses the electronic assembly. The cure tip consists of a silica-ETFE optical fiber, a stainless-steel fiber guide, a plastic housing and a ceramic ferrule. The detachable battery, charging base and power supply are manufactured from injection-molded plastic.
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    K Number
    K231387
    Device Name
    Endofill
    Manufacturer
    Lumendo AG
    Date Cleared
    2023-07-10

    (59 days)

    Product Code
    KIF
    Regulation Number
    872.3820
    Why did this record match?
    Applicant Name (Manufacturer) :

    Lumendo AG

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Endofill (1) is indicated for the permanent obturation of root canals following root canal treatment
    Device Description
    Endofill is a hydrophilic, radiopaque material intended for permanent obturation of the root canals following root canal treatment. It consists of a liquid, flowable material that is injected into the prepared and cleaned root canal and converted into a solid polymer by photocuring. The cured material remains within the root canal to obturate (seal) it. Endofill is provided ready-to-use in single-use plastic syringes which are sealed inside aluminum-laminate pouches. The Endofill material is the only part of the device that directly contacts the tissue. The syringe in which the material is provided comes in contact with Endofill material, so it contacts the tissue indirectly.
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