38d27f59-bb11-4716-a349-d517ad368503UpdatePublished42021-10-142016-08-152021-10-01Not in Commercial DistributionJ00666100PrimaryHIBCCAFFINIS66106610480017482Coltène/Whaledent AG1falsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse+41717575300info.ch@coltene.comK91248500035866Silicone dental impression materialAn elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient's teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.falseActiveELWMaterial, ImpressionSpecial Storage Condition, SpecifyKEEP AWAY FROM SUNLIGHTStorage Environment Temperaturefalsefalse