<?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>6a9c8eb4-f383-488e-b357-c0babf59eb3e</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2026-03-18</publicVersionDate><devicePublishDate>2026-03-10</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>E241VT0220</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>Cavex Bleach Transparent 1,0 mm</brandName><versionModelNumber>VT022</versionModelNumber><catalogNumber>VT022</catalogNumber><dunsNumber>419980156</dunsNumber><companyName>Cavex Holland B.V.</companyName><deviceCount>1</deviceCount><deviceDescription>Cavex Bleach Transparent 1,0 mm</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</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>true</otc><contacts><customerContact><phone>0235307725</phone><phoneExtension xsi:nil="true"/><email>m.vanderbor@cavex.nl</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63350</gmdnCode><gmdnPTName>Teeth whitening tray</gmdnPTName><gmdnPTDefinition>A custom-made device intended to retain a bleaching agent for whitening natural teeth through bleaching. It is made of polymer materials in the form of a mould to fit precisely over the teeth for a specified patient. This is a single-patient reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EHY</productCode><productCodeName>Tray, Impression, Preformed</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>