<?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>df0633b8-a0f9-44cc-9751-b2911d8fcad2</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2024-01-18</publicVersionDate><devicePublishDate>2024-01-10</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>03663394006972</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>AXIOM®</brandName><versionModelNumber>OPSA604</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>275978864</dunsNumber><companyName>ETABLISSEMENTS ANTHOGYR</companyName><deviceCount>1</deviceCount><deviceDescription>STD ABUTMENT ANALOG Ø6.0 H4</deviceDescription><DMExempt>true</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>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>61640</gmdnCode><gmdnPTName>Dental implant abutment analog, laboratory</gmdnPTName><gmdnPTDefinition>A rod-like device intended to be used as a copy of a dental implant abutment, for a dental laboratory working model, to confirm the orientation/position of the final dental implant; it may be used during a scanning procedure (e.g., with a laboratory scanner). This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NDP</productCode><productCodeName>Accessories, implant, dental, endosseous</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Coronal
height 4 mm</sizeText></deviceSize><deviceSize><sizeType>Outer Diameter</sizeType><size unit="Millimeter" value="6.0"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>