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510(k) Data Aggregation

    K Number
    K990680
    Device Name
    DENTEC LD 15 DIODE LASER
    Manufacturer
    DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
    Date Cleared
    1999-07-30

    (150 days)

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

    DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation, coagulation in oral soft tissue, for removal of diseased or inflamed soft tissue in the periodontal pocket and to perform pulpotomy and pulpotomy as adjunct to root canal therapy. Pulpotomy and pulpotomy as adjunct to rootcanal therapy - Endodontology / Removal of diseased or inflamed soft tissue in the periodontal - Periodontology / pocket ( sulcular debridement ) - Soft Tissue Gingivectomy, Gingival incision and excisionTissue retraction for impressions, Frenectomy, Treatment of aphtous ulcers, Excisional and incisional biopsies, Incising and draining of abscesses, Exposure of unerupted teeth, Hemostasis
    Device Description
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    K Number
    K974057
    Device Name
    DENTEK LD 15 LASERSYSTEM
    Manufacturer
    DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.
    Date Cleared
    1998-04-21

    (176 days)

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

    DENTEK LASERSYSTEMS PRODUKTIONS GES.M.B.H.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Intended Uses: The DENTEK LD 15 LaserSystem is intended for use for incision, excision, vaporization, ablation and coagulation and in oral soft tissue Indications for Use: - Soft Tissue . gingivectomy . gingival incisions and excisions . tissue retraction for impressions frenectomy . treatment of aphthous ulcers . excisional and incisional biopsies . incising and draining of abscesses . exposure of unerupted teeth . hemostasis
    Device Description
    Not Found
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