<?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>6c1dd501-5c47-4383-987d-2634b7eae1c7</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2025-02-13</publicVersionDate><devicePublishDate>2022-07-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08435451614735</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>KLOCKNER</brandName><versionModelNumber>SK-8025</versionModelNumber><catalogNumber>SK-8025</catalogNumber><dunsNumber>464517122</dunsNumber><companyName>SOADCO, S.L.</companyName><deviceCount>1</deviceCount><deviceDescription>SK2 LOW CRUCIFORM SCREW</deviceDescription><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>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>+376800593</phone><phoneExtension xsi:nil="true"/><email>calidad@soadco.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K010132</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>61647</gmdnCode><gmdnPTName>Dental prosthesis/implant abutment screw</gmdnPTName><gmdnPTDefinition>A device intended to be used short- or long-term to attach a dental implant abutment and/or prosthesis (e.g., crown, bridge) to a dental implant during dental restorative procedures. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. This is a single-use device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NHA</productCode><productCodeName>Abutment, implant, dental, endosseous</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>