Search Filters

Search Results

Found 2 results

510(k) Data Aggregation

    K Number
    K103114
    Device Name
    OSSPRAY SYLC CR
    Manufacturer
    OSSPRAY LTD
    Date Cleared
    2011-03-14

    (144 days)

    Product Code
    EJR
    Regulation Number
    872.6030
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSPRAY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    OSspray Sylc CR compound is a single-phase calcium phosphosilicate ceramic product intended for the removal of weakened or decayed small enamel lesions, in addition to the cleaning of enamel surfaces and providing relief of hypersensitivity associated with exposed dentin and open dentinal tubules.
    Device Description
    OSspray Sylc CR is a biologically-compatible device designed to selectively remove weakened or decayed carious enamel without damaging underlying healthy enamel in addition to cleaning tooth surfaces and closing exposed dentine tubules. The device when applied as a dry powder via an air polishing or air abrasion delivery system to a decayed enamel surface will abrade away the decayed tissue. The process of cleaning the tooth surface physically occludes exposed dentin tubules for the management of sensitive teeth. OSspray cares removal powder is a dry inorganic particulate, (calcium phosphosilicate), composed of elements that occur naturally in the body's hard tissues (Ca, Na, Si, P, and O). To aid powder flow less than 2% by weight of silicon dioxide (Aerosil R972 Pharma) is added to the calcium phosphosilicate.
    Ask a Question
    K Number
    K100833
    Device Name
    SYLE SMARTIP
    Manufacturer
    OSSPRAY LTD
    Date Cleared
    2010-06-03

    (71 days)

    Product Code
    EFB
    Regulation Number
    872.4200
    Why did this record match?
    Applicant Name (Manufacturer) :

    OSSPRAY LTD

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    SylcTM SmarTip™ is a disposable, single-use device containing OSspray Cleaning Compound powder, intended for prophylaxis and polishing of dental enamel surfaces and rapid relief of hypersensitivity associated with exposed tooth dentin. Studies have shown that Sylc™ SmarTip™ is effective at occluding exposed dentinal tubules, which has been shown in the literature to be associated with a reduction in hypersensitivity.
    Device Description
    Sylc™ SmarTip™ is a single-use, disposable hand-held device that utilizes a standard dental hand piece air source, and is designed to project a stream of dry particulate onto a tooth surface to clean tooth surfaces and close exposed dentin tubules. The process of cleaning the tooth surface physically occludes dentin tubules for the management of sensitive teeth. The powder chamber contains OSspray Cleaning Compound (K062502) which is a dry inorganic particulate, (calcium sodium phosphosilicate). When exposed to an aqueous environment, the material undergoes a rapid surface reaction, allowing it to physically adhere to exposed dentin and to physically occlude tubules. Within a short period of time, essentially all of the particles react to form hydroxycarbonate apatite (HCA), which is chemically and structurally similar to natural tooth mineral.
    Ask a Question

    Page 1 of 1