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510(k) Data Aggregation

    K Number
    K042114
    Device Name
    MDL SERIES DIODE LASERS, MODEL MDL-10/15
    Date Cleared
    2006-02-03

    (547 days)

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

    VISION LASERTECHNIK, GMBH

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The MDL Laser System is intended for use as a dental laser, with specific application in oral soft tissue for incision, excision, vaporization, ablation and coagulation. Indications for use include the following: Excisional and incisional biopsies Exposure of unerupted teeth Fibroma removal Frenectomy Frenotomy Gingival troughing for crown impressions Gingivectomy Gingivoplasty Gingival incision and excision Hemostasis and coagulation Implant recovery Incision and drainage of abscess Loukoplakia Operculectomy Oral papillectomies Pulpotomy Pulpotomy as an adjunct to root canal therapy Reduction of gingival hypertrophy Soft tissue crown lengthening Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa. Vestibuloplasty
    Device Description
    Not Found
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