4709b61c-9bd7-4730-8c9b-221eddb20ddfUpdatePublished42022-10-312016-09-24In Commercial DistributionD813SPD16111PrimaryHIBCCD813SPD16110Unit of UseHIBCCSplashMax®SPD1611SPD1611809857704DEN-MAT HOLDINGS, LLC2SPLASHMAX CRT REG SET MED 2PKfalsefalsefalsefalsefalsefalsetruefalsefalsetruefalsefalsefalseLabeling does not contain MRI Safety Informationtruefalse1-800-433-6628info@denmat.com35866Silicone 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, ImpressionHandling Environment TemperatureStorage Environment TemperatureSpecial Storage Condition, SpecifyKeep drySpecial Storage Condition, SpecifyDo not expose to direct sunlightfalsefalse