<?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>236078f1-c743-4d51-a57c-8b780a3fc37c</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2022-10-03</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate>2021-08-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D0026510071</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>Caulk® Orthodontic Resin</brandName><versionModelNumber>651007</versionModelNumber><catalogNumber>651007</catalogNumber><dunsNumber>083235549</dunsNumber><companyName>DENTSPLY INTERNATIONAL INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Caulk® Orthodonic Resin, Liquid, Pink, Regular Package</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>false</rx><otc>false</otc><contacts><customerContact><phone>+1(800)532-2855</phone><phoneExtension xsi:nil="true"/><email>MilfordDE-Customer-Service@dentsplysirona.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>31783</gmdnCode><gmdnPTName>Temporary dental crown/bridge</gmdnPTName><gmdnPTDefinition>A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EBI</productCode><productCodeName>RESIN, DENTURE, RELINING, REPAIRING, REBASING</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Weight</sizeType><size unit="Gram" value="605"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="430"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>1 Powder (605g), 1 Liquid-Pink (430mL), 1 Separator (65mL), 1 Liquid Dispenser (empty), Accessories</sizeText></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from sunlight.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>