<?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>b5fa4c43-8e69-4916-9d85-af7204fe8949</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2019-06-14</publicVersionDate><devicePublishDate>2019-06-06</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>E22124091</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><identifier><deviceId>E2212409</deviceId><deviceIdType>Unit of Use</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>Individo Lux</brandName><versionModelNumber>2409</versionModelNumber><catalogNumber>2409</catalogNumber><dunsNumber>316699578</dunsNumber><companyName>VOCO GmbH</companyName><deviceCount>50</deviceCount><deviceDescription>lndivido Lux blue opaque and lndivido Lux transparent blue are opaque
respectively transparent light-curing resins in form of contoured plates for
maxillae and mandibles for the fabrication of individual trays for use in crown,
bridge and total prosthetic technique as well as for the fabrication of bases
for bite patterns and odontograms. They are ready for use and easy to handle
without any odor nuisance.</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>true</rx><otc>false</otc><contacts><customerContact><phone>999-999-9999</phone><phoneExtension xsi:nil="true"/><email>xxx@xx.xx</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34808</gmdnCode><gmdnPTName>Dental base plate</gmdnPTName><gmdnPTDefinition>A foundation on which an occlusal rim is built or a trial denture set-up. Dental base plates are made of wax, shellac or polymers and formed individually for one patient (custom-made). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EBH</productCode><productCodeName>Material, Impression Tray, Resin</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>