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    K Number
    K223340
    Device Name
    EDS Calculus Softener TURBO CR
    Manufacturer
    Essential Dental Systems Inc.
    Date Cleared
    2023-12-11

    (405 days)

    Product Code
    ELC
    Regulation Number
    872.4850
    Why did this record match?
    Applicant Name (Manufacturer) :

    Essential Dental Systems Inc.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
    Intended Use
    Softens dental calculus, tartar, and/or plaque to facilitate easier removal; Reduces scaling time; May be used in hand and ultrasonic scaling procedures.
    Device Description
    EDS Calculus Softener (TURBO-CR™) is a professional use only product to be used by a dental hygienist to aid in the cleaning and removal of dental plaque, mineralized calculus and/or tartar from subgingival root surfaces and supragingival areas of teeth. The composition helps remove the etiological factors which have been implicated in fostering periodontal disease. The device contains chelating agents and detergents which reduce the hardness of mineralized plaque, calculus, and/or tartar. It consists of two component pastes that are combined in a dual barrel syringe for ease of dispensing and consistent dosage. The device contains an alkaline paste which effervescences or foams upon mixing through a mixing tip. This effervescence helps drive the activated composition into the "hard to reach" interproximal spaces between teeth as into the subgingival regions where tartar/plaque and or dental calculus can accumulate. It is packaged in the familiar double-barrel syringe configuration used by numerous other dental materials. The double barrel syringe is placed into a manual cartridge gun (commonly available at the dental clinic) and the composition is dispensed into a dental tray which is then placed over the patient's dental arch for cleaning. The steps required to properly express the calculus softening composition are: remove cap, attach mixer, place into manual cartridge gun, express the material into a dental tray, and then place into the patient's mouth over the dental arch to be cleaned/debrided for 60 seconds. The patient is then instructed to rinse and the dental scaling can commence by the dental hygienist. After use, the mixer/dispensing tip and dental tray should be discarded and the cap replaced. The device is provided non-sterile and does not contain fluoride or any whitening agents.
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