<?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>30e95849-9944-4d7a-9c32-7cc988574e3d</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-03-18</publicVersionDate><devicePublishDate>2025-03-10</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>EBREVLCOLBODYD9</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>EBREVLCOLBODYD0</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate>2025-03-10</pkgDiscontinueDate><pkgStatus>Not in Commercial Distribution</pkgStatus><pkgType>dummy</pkgType></identifier><identifier><deviceId>EBREVLCOLBODYD0</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>visio.lign color Body D</brandName><versionModelNumber>VLCOLBODYD</versionModelNumber><catalogNumber>VLCOLBODYD</catalogNumber><dunsNumber>341086190</dunsNumber><companyName>bredent GmbH &amp; Co. KG</companyName><deviceCount>1</deviceCount><deviceDescription>visio.lign color Body D  2.6 ml</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>MR Safe</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+4907309872451</phone><phoneExtension xsi:nil="true"/><email>info@bredent.com</email></customerContact><customerContact><phone>+4907309872531</phone><phoneExtension xsi:nil="true"/><email>regulatory-affairs@bredent.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K240735</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>EBD</productCode><productCodeName>Coating, filling material, resin</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>keep out of sunlight</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>