<?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>ec0f3887-968b-450c-9b68-f61c7df29b1b</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2022-03-25</publicVersionDate><devicePublishDate>2019-11-28</devicePublishDate><deviceCommDistributionEndDate>2022-03-24</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10697660004591</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Hard Inlay Wax (green chunks)</brandName><versionModelNumber>5313-1</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>257382580</dunsNumber><companyName>Oculo-Plastik Inc</companyName><deviceCount>1</deviceCount><deviceDescription>Hard Inlay Wax (green chunks)</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>514-381-3292</phone><phoneExtension xsi:nil="true"/><email>sales@oculoplastik.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34807</gmdnCode><gmdnPTName>Wax dental impression material</gmdnPTName><gmdnPTDefinition>A material made of wax, sometimes in combination with resins of low melting point, designed to reproduce the structure of a patient&apos;s teeth and gums, or other oral anatomy, after being placed on an impression tray and inserted into the mouth. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EGD</productCode><productCodeName>Wax, Dental, Intraoral</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Weight</sizeType><size unit="Gram" value="454"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Weight</sizeType><size unit="Pound" value="1"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>