<?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>cb7587ed-7082-452e-ba29-1092dc803e2e</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-01-13</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate>2025-01-12</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>DO3640050002</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>DO3640050000</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>PERMITE</brandName><versionModelNumber>PERMITE 5SP REG 50</versionModelNumber><catalogNumber>4005000</catalogNumber><dunsNumber>753221852</dunsNumber><companyName>SDI LIMITED</companyName><deviceCount>50</deviceCount><deviceDescription xsi:nil="true"/><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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>+18002285166</phone><phoneExtension xsi:nil="true"/><email>info@sdi.com.au</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K801639</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>34836</gmdnCode><gmdnPTName>Dental amalgam alloy</gmdnPTName><gmdnPTDefinition>A composite of metals in fine particles, consisting mainly of silver (Ag), tin (Sn) and small amounts of copper (Cu), that is intended for mixing with mercury (Hg) to produce dental amalgam. Amalgam is a dental restorative material used to fill tooth cavities. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EJJ</productCode><productCodeName>Alloy, amalgam</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Handling Environment Atmospheric Pressure</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="25"/><storageHandlingLow unit="Degrees Celsius" value=""/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>