<?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>b86251c8-8f07-4d2a-a111-be6dabc2b8c5</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2023-08-22</publicVersionDate><devicePublishDate>2019-08-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D745701176COM02090</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>Inclusive</brandName><versionModelNumber>70-1176-COM0209</versionModelNumber><catalogNumber>70-1176-COM0209</catalogNumber><dunsNumber>022761689</dunsNumber><companyName>Prismatik Dentalcraft, Inc</companyName><deviceCount>1</deviceCount><deviceDescription>Inclusive Titanium Scanning Abutment Screw compatible with: Dentsply Implants Astra Tech Implant System EV 4.8/5.4</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>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+1(800)854-7256</phone><phoneExtension xsi:nil="true"/><email>xx@xx.xx</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>61646</gmdnCode><gmdnPTName>Dental prosthesis/implant abutment screw analog, reusable</gmdnPTName><gmdnPTDefinition>A device intended to be used as a copy of a dental implant prosthetic screw to attach a dental implant abutment or prosthesis (e.g., crown, bridge) to a dental implant analog in a dental laboratory working model. Also known as guide pin, it may also be used intraorally to attach an implant coping to the dental implant during an open-tray impression procedure. It is made of metal [e.g., titanium (Ti)] and consists of a rod-like fastener inserted through the abutment/prosthesis. 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/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>