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510(k) Data Aggregation

    K Number
    K961472
    Device Name
    DENTAL DAM SILICONE
    Date Cleared
    1996-08-07

    (112 days)

    Product Code
    Regulation Number
    872.6300
    Why did this record match?
    Applicant Name (Manufacturer) :

    WORLDWIDE DENTAL, INC.

    AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
    Intended Use
    The Roeko silicone dam is intended for use as a physical barrier around a tooth to allow isolation from fluids in the mouth during dental procedures. The tooth is isolated by insertion through a hole punched in the center of the silicone sheet. The dental dam is inserted into the oral cavity using frame and clamp accessories. These indications are the same as those claimed for the predicate device.
    Device Description
    The Roeko Dental Dam Silicone. Its common name is dental dam and the classification name is Rubber dam and accessories. The Roeko dam is a silicone product used in dental procedures. The device consists of a 150 mm x 150 mm green opaque film of less than 1mm in thickness. The device is available with frame, clamp and other accessories for use in dental procedures.
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