<?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>d12e765c-77a0-4e3e-a499-a2d3569cd970</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-07-12</publicVersionDate><devicePublishDate>2023-07-04</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08809822765249</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>Impression Coping</brandName><versionModelNumber>BDICPNB5007</versionModelNumber><catalogNumber>BDICPNB5007T</catalogNumber><dunsNumber>687388178</dunsNumber><companyName>Megagen Implant Co. Ltd</companyName><deviceCount>1</deviceCount><deviceDescription>BLUEDIAMOND Implant System
Ø5/ C3/ L7/ Pickup/ NC/ Bridge [8Ncm]
</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>true</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>64321</gmdnCode><gmdnPTName>Dental precision attachment simulator/analog, single-use</gmdnPTName><gmdnPTDefinition>A device intended to be used to imitate or copy a dental precision attachment, or element that is part of a precision attachment, during fabrication of a final dental prosthesis (e.g., denture, crown, bridge) in the dental laboratory. It may be an instrument designed to reproduce the position, shape, and dimensions of a precision attachment, or it may be a copy of a precision attachment designed to enable fabrication of, or correct incorporation of, the final precision attachment in the dental prosthesis. This is a single-use 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>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>