<?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>1f350ccc-d212-4547-8a1c-e75964d56f36</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-09-09</publicVersionDate><devicePublishDate>2022-09-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EDMG1107800</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><identifier><deviceId>EDMG1107801</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>LuxaPost</brandName><versionModelNumber>110780</versionModelNumber><catalogNumber>110780</catalogNumber><dunsNumber>320744915</dunsNumber><companyName>DMG Chemisch-Pharmazeutische Fabrik GmbH</companyName><deviceCount>1</deviceCount><deviceDescription>Core-build-up and post cementation. Content: 5 posts Ø 1.25 mm, 5 posts Ø 1.375 mm, 5 posts Ø 1.5 mm, 1 drill Ø 1.25 mm, 1 drill Ø 1.375 mm, 1 drill Ø 1.5 mm, 30 silicone stops.
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>true</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>201-894-5505</phone><phoneExtension xsi:nil="true"/><email>ccosta@dmg-america.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>45650</gmdnCode><gmdnPTName>Root canal post kit</gmdnPTName><gmdnPTDefinition>A collection of dental devices intended for use during insertion of a root canal post(s), sometimes with core build-up. This device typically includes a prefabricated root canal post(s), drill(s), thread cutter, and may include core-build-up materials such as applicator (dispensing gun), dental composite resin(s), dentine bonding agent, and etching solution. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ELR</productCode><productCodeName>Post, Root Canal</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="1.25"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="1.375"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="1.5"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Celsius" value="25"/><storageHandlingLow unit="Degrees Celsius" value="2"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="77"/><storageHandlingLow unit="Degrees Fahrenheit" value="36"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Protect against chemical vapors.</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Liquid Chemical</sterilizationMethod></methodTypes></sterilization></device>