<?xml version='1.0' encoding='UTF-8'?><device xmlns='http://www.fda.gov/cdrh/gudid' xmlns:xsi='http://www.w3.org/2001/XMLSchema-instance'><publicDeviceRecordKey>443e408c-8e40-4a0d-a213-63d273042144</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2019-04-01</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate>2019-01-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M595S4381</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>M595S4380</containsDINumber><pkgQuantity>2</pkgQuantity><pkgDiscontinueDate>2019-01-01</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>M595S4380</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Blu-Mousse®</brandName><versionModelNumber>S438</versionModelNumber><catalogNumber>S438</catalogNumber><dunsNumber>009900424</dunsNumber><companyName>PARKELL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Classic Blu-Mousse® Standard-Cartridge System</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>6312491134</phone><phoneExtension xsi:nil="true"/><email>customerservice@parkell.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35866</gmdnCode><gmdnPTName>Silicone dental impression material</gmdnPTName><gmdnPTDefinition>An elastomeric, polysiloxane-based material capable of reacting to form a rubber-like substance suitable to reproduce the structure of a patient&apos;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.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ELW</productCode><productCodeName>Material, Impression</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="75"/><storageHandlingLow unit="Degrees Fahrenheit" value="64"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store at room temperature. Avoid excessive heat, light, moisture or freezing.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>