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510(k) Data Aggregation

    K Number
    K232827
    Device Name
    LightForce Orthodontic System
    Manufacturer
    LightForce Orthodontics
    Date Cleared
    2023-09-14

    (1 days)

    Product Code
    NJM, PNN
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LightForce Orthodontics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
    Device Description
    The LightForce Orthodontic System (LFO System) is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific placement jigs, and TPS that allows the orthodontist to view, measure, and diagnose cases. The patient-specific brackets are available with slot sizes to orthodontic wires up to 0.022" in height and come in a variety of hook options colors and shades. The patient-specific placement jig is an optional-use lab device to aid orthodontists in bracket placement and bonding and is composed of an FDA cleared, class 1 certification material. The LFO system does not contain commercially available or patient-specific shaped arch wires, ligatures, or adhesives that affix the brackets to the teeth. The LFO system packaging consists of a single product offering box with indirect bonding trays (IDB trays) loaded with brackets as well as a secondary set of individual brackets and, where applicable IDB trays and/or bite turbo indirect bonding travs. The LFO system may also include non-patient-specific brackets for temporary use with predetermined torque, tip, offset and base contour, packaged and labeled separately. The inclusion of an optional self ligating metal clip is to ligate a wire to the bracket by encapsulating the wire in the slot of the bracket.
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    K Number
    K222764
    Device Name
    LightForce Orthodontic System
    Manufacturer
    LightForce Orthodontics
    Date Cleared
    2022-09-14

    (1 days)

    Product Code
    NJM, PNN
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LightForce Orthodontics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightForce Orthodontic System is a treatment planning software and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
    Device Description
    The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The orthodontist uses the TPS (K200148) to select and order the patient-specific orthodontic brackets. The TPS allows the orthodontist to diagnose the patient, plan treatment, and position the orthodontic brackets based on a digital impression of the patient - the outcome of the TPS is a prescription for the patient-specific orthodontic brackets. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring, and modifying cases. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth.
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    K Number
    K200148
    Device Name
    LightForce Orthodontic System (LFO System)
    Manufacturer
    LightForce Orthodontics
    Date Cleared
    2020-02-21

    (30 days)

    Product Code
    NJM, PNN
    Regulation Number
    872.5470
    Why did this record match?
    Applicant Name (Manufacturer) :

    LightForce Orthodontics

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The LightForce Orthodontic System is a treatment planning software (TPS) and Orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances.
    Device Description
    The LightForce Orthodontic System (LFO System) is a treatment planning software (TPS) and orthodontic appliance system used to correct malocclusions in orthodontic patients using patient-matched orthodontic appliances. The LFO System consists of patient-specific ceramic brackets, patient-specific bracket placement jigs, arch wire templates, and a TPS for viewing, measuring,modifying cases and submitting orders. LightForce Orthodontics' (LFO) operators and the orthodontists use the TPS to generate a prescription of their choosing. LFO then manufactures the patient-specific brackets and placement jigs using proprietary additive manufacturing techniques. The orthodontist then bonds the brackets to the teeth using the optional placement jig and ligates wires to enable tooth movement. The LFO System does not contain commercially-available or patient-specific shaped arch wires, ligatures, or adhesives that affixes the brackets to the teeth. The change is to upgrade LFO System's Treatment Planning Software (TPS) from version 3.1 to version 4.0. TPS version 3.1 was originally cleared in K183542 and the LFO System was originally cleared in K181271. TPS version 4.0 provides improved software architecture, updated hosting infrastructure and improvements to the user interface to better match the intended use of the product based on customer feedback and validation input. A comparison of TPS 3.1 and TPS 4.0 shows that both software provide the same features and functional workflows is evidence of substantial equivalence. The replacement software is identical in performance and function to the previously used software.
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