<?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>cdd1e0e7-997d-49a5-8c3b-ffbb6351f813</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2026-01-23</publicVersionDate><devicePublishDate>2021-05-01</devicePublishDate><deviceCommDistributionEndDate>2026-01-22</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D746RBTPC1</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>RETAINER BRITE®</brandName><versionModelNumber>RB-TP-C</versionModelNumber><catalogNumber>RB-TP-C</catalogNumber><dunsNumber>116903307</dunsNumber><companyName>DENTSPLY SIRONA ORTHODONTICS INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Retainer Brite® Patient PAK 100PK</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</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>false</rx><otc>true</otc><contacts><customerContact><phone>+1(844)848-0137</phone><phoneExtension xsi:nil="true"/><email>essix.sales@dentsplysirona.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44736</gmdnCode><gmdnPTName>Orthodontic appliance cleanser</gmdnPTName><gmdnPTDefinition>An agent used to remove soft debris, plaque and stain build-up from the surface of removable orthodontic aligners or retainers. It is normally used at home by the wearer of the appliance, and is typically supplied as tablets or crystals used to make a solution that removes and/or dissolves debris or accretions. This device may need to be used in conjunction with an electrical or mechanical cleansing device. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EFT</productCode><productCodeName>CLEANSER, DENTURE, OVER THE COUNTER</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>