<?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>80254a6a-8ea1-49fb-b54d-e8f1dedd5b58</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2018-12-07</publicVersionDate><devicePublishDate>2016-09-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EAGNETK3PRO3SET0</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>K3Pro Konus Dental Implants</brandName><versionModelNumber>ETK3Pro/3.Set</versionModelNumber><catalogNumber>ETK3Pro/3.Set</catalogNumber><dunsNumber>312649568</dunsNumber><companyName>Argon Medical Productions &amp; Vertriebs Gesellschaft mbH &amp; Co. KG</companyName><deviceCount>1</deviceCount><deviceDescription>Transfer for closed tray impression K3Pro 3mm
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</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>true</rx><otc>false</otc><contacts><customerContact><phone>+49672130960</phone><phoneExtension xsi:nil="true"/><email>info@argon-dental.de</email></customerContact><customerContact><phone>+17158981434</phone><phoneExtension xsi:nil="true"/><email>purchasing@argondentalusa.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K141159</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>46122</gmdnCode><gmdnPTName>Dental implant suprastructure, temporary, preformed, reusable</gmdnPTName><gmdnPTDefinition>A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It includes fixture impression pick-ups and replica devices and is available in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a reusable device.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NDP</productCode><productCodeName>Accessories, Implant, Dental, Endosseous</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>