<?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>2b21599e-944b-4e1f-96bf-0270d3d62bd4</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2025-07-14</publicVersionDate><devicePublishDate>2016-10-26</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D8370545010</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>Hydroxyline</brandName><versionModelNumber>Thinner - TC - 50cc (2 oz)</versionModelNumber><catalogNumber>05-4501</catalogNumber><dunsNumber>067488114</dunsNumber><companyName>Taub Products</companyName><deviceCount>1</deviceCount><deviceDescription>HYDROXYLINE - Calcium Hydroxide Cavity Liner TC Thinner is used to thin out the Liquid due to evaporation or need to change viscosity.  Hydroxyline is a thin &apos;varnish&apos; film that forms a chemical and physical barrier that seals tubules and protects the pulp from acids in cements and acid etching solutions. Use it under both temporary and permanent cementation to protect the pulp. It will prevent thermal and &apos;pulp&apos; shock.</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>false</rx><otc>false</otc><contacts><customerContact><phone>+1.201.798.5353</phone><phoneExtension xsi:nil="true"/><email>customerservice@taubdental.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35698</gmdnCode><gmdnPTName>Dental cavity varnish</gmdnPTName><gmdnPTDefinition>A liquid substance used in dentistry consisting of one or more resins in an organic solvent, used for the protection of pulpal tissue and to provide a marginal seal to newly placed amalgam restorations. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EJK</productCode><productCodeName>Liner, Cavity, Calcium Hydroxide</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Total Volume</sizeType><size unit="Milliliter" value="50"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Keep away from open flame. See SDS.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>