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510(k) Data Aggregation

    K Number
    K981565
    Device Name
    BIOCLEAR CONCENTRATE
    Date Cleared
    1998-10-15

    (167 days)

    Product Code
    Regulation Number
    872.6640
    Why did this record match?
    Applicant Name (Manufacturer) :

    WAGGONER PRODUCT DEVELOPMENT

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    BioClear Concentrate is intended to be diluted daily into tap water and placed in an independent dental reservoir bottle system, which would act as the sole supply of water for the Dental Operative Unit. There, the diluted BioClear Concentrate would act as a constantly present, potable, antimicrobial agent. It has been found to aid in the control of the microbial population in dental unit waterlines.
    Device Description
    The BioClear Concentrate is intended to be added to an independent water supply system reservoir bottle and would act as a constantly present disinfectant agent in the dental operative unit. It has been found to aid in the control of the microbial population in dental unit waterlines. A number of independent water systems can be purchased separately and retrofitted to a pre-existing dental operative unit or can easily be found included on a large number of newer dental operative units and are often referred to as a "clean water" systems. The BioClear Concentrate is composed of 16% Citric Acid. U.S.P./F.C.C. as the only active ingredient. Other GRAS chemicals, 14.3% glucose F.C.C., 0.8% Aspartame F.C.C., and 0.25% Sodium Benzoate F.C.C. ( which only acts as a preservative for the concentrate), and 0,008% FD & C Blue #1, The artificial and natural sweeteners are added only to offer an agreeable flavor. The blue color is added to ensure the BioClear Concentrate has, in fact, been added to the tap water. The BioClear Concentrate would be mixed with tap water in a ratio of 7 ml/ 500 ml +/-0.5ml to produce a final concentration of 0.224% citric acid, and would be changed daily. The dental operative unit should be purged/ flushed for 15 seconds every morning for the first 3 weeks. After this period of time, although recommended, it makes virtually no difference. All of these chemicals are Generally Recognized as Safe (GRAS) as per the FDA.
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