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510(k) Data Aggregation

    K Number
    K221761
    Device Name
    Solea
    Manufacturer
    Convergent Dental, Inc.
    Date Cleared
    2022-09-14

    (89 days)

    Product Code
    NVK, GEX
    Regulation Number
    878.4810
    Why did this record match?
    Applicant Name (Manufacturer) :

    Convergent Dental, Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Solea system is indicated for the following: - Ablation of hard tissue for caries removal and cavity prevention - Incision, excision, vaporization, coagulation and hemostasis of soft tissue in the oral cavity - Cutting, shaving, contouring and resection of oral osseous tissue (both) - Aiding in the reduction of mineral loss in dental enamel
    Device Description
    The Solea system is a mobile, cart-based dental treatment system that uses pulsed laser energy for ablation of hard tissue for caries removal and cavity preparation; incision, excision, vaporization, coagulation, and hemostasis of soft tissue in the oral cavity; cutting, shaving, contouring and resection of oral osseous tissue (bone). The Solea system utilizes CO2 laser technology with a wavelength of 9.3 um. The modification to the cleared Solea system is the introduction of the DR Handpiece which allows the system to deliver controlled sub-ablative energy necessary to heat the tooth surface mineral without ablation for the new treatment of aiding in the reduction of mineral loss in the tooth enamel.
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