<?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>6e0f4f03-5b31-4b4b-a3b6-520fcf105f98</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2019-01-24</publicVersionDate><devicePublishDate>2016-09-15</devicePublishDate><deviceCommDistributionEndDate>2019-01-24</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>J011100120000</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>remanium®</brandName><versionModelNumber>100-120-00</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>315427286</dunsNumber><companyName>DENTAURUM GmbH &amp; Co.KG</companyName><deviceCount>1</deviceCount><deviceDescription>remanium® secura allergy plates</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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>+1(800)523-3946</phone><phoneExtension xsi:nil="true"/><email>info@dentaurum-us.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35857</gmdnCode><gmdnPTName>Dental casting non-noble alloy</gmdnPTName><gmdnPTDefinition>A material composed primarily of non-noble metals [e.g., includes alloys such as cobalt-chrome (Co-Cr), nickel-chromium, titanium (Ti)] intended for use in the fabrication of a dental cast [i.e., a positive copy of a part of the oral anatomy made in an impression (mould), such as a dental crown] or dental restorations and appliances (e.g., porcelain-fused-to-metal crowns and bridge restorations). It is typically available in the form of small ingots or bars that are melted and poured into an impression. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EJH</productCode><productCodeName>ALLOY, METAL, BASE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>No special storage conditions required</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>