Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K083516
    Device Name
    PERIOGENIX
    Manufacturer
    OROSCIENCE, INC.
    Date Cleared
    2009-02-20

    (86 days)

    Product Code
    EMA
    Regulation Number
    872.3275
    Why did this record match?
    Applicant Name (Manufacturer) :

    OROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Periogenix is a periodontal wound dressing intended to protect injured periodontal tissue (gums) by forming a temporary physical barrier to avoid further irritation.
    Device Description
    Periogenix consists of thirty (30) disposable, single use dental trays and a canister of topical periodontal paste (TPP). The TPP is dispensed into the single use disposable dental tray, which together provide a moist temporary physical barrier that covers the site of application to avoid further irritation.
    Ask a Question
    K Number
    K082445
    Device Name
    CURATIVE980 DIODE LASER
    Manufacturer
    OROSCIENCE, INC.
    Date Cleared
    2008-10-15

    (51 days)

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

    OROSCIENCE, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended for use in the medical specialty of dental surgery. The Curative980 Diode Lasers (and the delivery accessories that are used with them to deliver laser energy) is indicated for use in a variety of applications requiring incision, excision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery. The Curative980 Diode Lasers and the delivery accessories that are used with them to deliver laser energy are intended to deliver laser energy for incision, ablation, vaporization, coagulation and hemostasis of soft tissue in the medical specialty of dental surgery as follows: Dental Surgery Indicated for incision, excision, vaporization, ablation and coagulation of oral soft tissue (intraoral and extraoral) including marginal and inter-dental gingival and epithelial lining of free gingival and the following specific indications: - Biopsy - Excisional and incisional biopsies - Excision of lesions - Exposure of unerupted/partially erupted teeth - Fibroma removal - Frenectomy - Frenotomy - Gingival troughing for crown impressions - Gingival troughing - Gingivectomy - Gingivoplasty - Gingival incision and excision - Hemostasis and coagulation - Hemostasis of donor site - Implant recovery - Removal of granulation tissue - Laser assisted flap surgery - Debridement of diseased epithelial lining - Treatment of aphthous ulcers - Sulcular debridement (removal of diseased or inflamed soft-tissue in the periodontal pocket to improve clinical indices including gingival index, gingival bleeding index, probe depth, attachment loss and tooth mobility) - Laser soft tissue curettage - Treatment of canker sores, herpetic and aphthous ulcers of the oral mucosa - Operculectomy - Incision and drainage of abscess - Oral papillectomies; papillectomy - Removal of hyperplastic tissues - Pulpotomy - Pulpotomy as an adjunct to root canal therapy - Reduction of gingival hypertrophy - Reduction of bacterial level (decontamination) and inflammation - Soft tissue crown lengthening; crown lengthening - Tissue retraction for impressions - Leukoplakia - Vestibuloplasty - Light activation of bleaching materials for teeth whitening. - Laser-assisted bleaching/whitening for teeth
    Device Description
    The Curative980 Diode Lasers are comprised of the following main components: - Main console containing the major electrical components, including: - Control Touch-Screen Display Panel including touch controls; - 980 nm treatment laser (aluminum gallium arsenide (AlGaAs) solid state laser diode); - 650 nm aiming beam diode laser; - Delivery device fiber-optic connector port; - Emergency stop switch; - Remote interlock connector (External door interlock connector); - Connector ports for the footswitch and power cord; - Handpiece holder (attaches to the top of the laser system console); - Fiber Spool (secures and organizes the optical fiber) attaches to the side of the main console; - Footswitch: - Medical grade power cord; - Delivery Devices: - Optical Fibers - Reusable, cleanable, sterilizable optical fibers; - Handpieces -Reusable, cleanable, sterilizable handpieces; - Handpiece Tips - Disposable single-use tips; - Accessories: - Safety Glasses - Tools: - Optical Fiber Striper; - Optical Fiber Cleaver.
    Ask a Question

    Page 1 of 1