<?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>42050260-93dd-4e94-a332-7dbf71bf1870</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2021-02-11</publicVersionDate><devicePublishDate>2021-02-03</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>E23523920</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>CERAMAGE</brandName><versionModelNumber>2392</versionModelNumber><catalogNumber>2392</catalogNumber><dunsNumber>054618202</dunsNumber><companyName>SHOFU DENTAL CORPORATION</companyName><deviceCount>1</deviceCount><deviceDescription>CERAMAGE GUM-D 5G</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>true</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>+1(800)827-5262</phone><phoneExtension xsi:nil="true"/><email>customer-service@shofu.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K050401</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>38781</gmdnCode><gmdnPTName>Dental prosthesis veneer resin</gmdnPTName><gmdnPTDefinition>A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EBF</productCode><productCodeName>MATERIAL, TOOTH SHADE, RESIN</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>