090542b9-59b2-417f-8dc4-e4a21d95bc2eNewPublished12019-03-112019-02-11In Commercial DistributionD661H080401PrimaryHIBCCD661H080400Unit of UseHIBCCWedjetsH08040622185718COLTENE/WHALEDENT INC42Wedjet Extra Small falsefalsefalsefalsefalsetruetruefalsefalsetruefalsetruefalseLabeling does not contain MRI Safety InformationtruefalseK90084400011155Rubber dam, Hevea-latexA sheet of elastomeric material made of Hevea natural rubber latex (NRL) that is punched with holes and placed over the teeth during dental procedures. It can have a variety of functions such as: 1) to isolate the field of operation from the rest of the oral cavity; 2) to eliminate saliva; 3) to prevent the patient swallowing liquid/dental material; 4) to protect soft tissue from harmful solutions; and 5) to reduce risk of infection. This is a single-use device.falseActiveEIEDam, RubberHandling Environment TemperatureStorage Environment Temperaturefalsefalse