<?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>a6390635-4ba8-4a0b-a662-db48c1f54786</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-04-17</publicVersionDate><devicePublishDate>2024-04-09</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EGEBADW98300</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>VITA VIONIC WAX</brandName><versionModelNumber>ADW9830</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>315165357</dunsNumber><companyName>Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung &amp; Co Kommanditgesellschaft</companyName><deviceCount>1</deviceCount><deviceDescription>VITA VIONIC WAX, White, Ø 98.4 x h 30 mm, 1 pc.</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>true</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>+1(800)8283839</phone><phoneExtension xsi:nil="true"/><email>info@vitanorthamerica.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>16189</gmdnCode><gmdnPTName>Dental casting wax</gmdnPTName><gmdnPTDefinition>A waxy dental material used to make patterns in the production of fixed dental prosthetic restorations by the &quot;lost-wax&quot; casting technique. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EGD</productCode><productCodeName>WAX, DENTAL, INTRAORAL</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>