<?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>d690ac15-0411-4085-ba2f-4e3f0982a1fa</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2019-04-15</publicVersionDate><devicePublishDate>2018-02-12</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>ESTOU0002X2650</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>StecoTitanmagnetics®</brandName><versionModelNumber>U.00.02.X265</versionModelNumber><catalogNumber>U.00.02.X265</catalogNumber><dunsNumber>389566209</dunsNumber><companyName>steco-System-Technik GmbH &amp; Co KG</companyName><deviceCount>1</deviceCount><deviceDescription>Titanmagnetics® epitheses magnet X-Line D4.8/H2.65 universal with retention ring for silicone -&gt; For further information visit steco.de
</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>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+49405577810</phone><phoneExtension xsi:nil="true"/><email>info@steco.de</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>38578</gmdnCode><gmdnPTName>Magnetic dental precision attachment</gmdnPTName><gmdnPTDefinition>A device with magnetic properties designed for fixation of a removable dental prosthesis.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KCZ</productCode><productCodeName>Prosthesis, Breast, External, Used With Adhesive</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>