<?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>70604b79-47e6-4b45-aed9-3362864e2684</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2024-02-29</publicVersionDate><devicePublishDate>2016-09-24</devicePublishDate><deviceCommDistributionEndDate>2021-02-19</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D746MTMLALDA21</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>MTML-Clear Aligner</brandName><versionModelNumber>MTML-AL-DA2</versionModelNumber><catalogNumber>MTML-AL-DA2</catalogNumber><dunsNumber>116903307</dunsNumber><companyName>DENTSPLY SIRONA ORTHODONTICS INC.</companyName><deviceCount>1</deviceCount><deviceDescription>MTML-Clear Aligner-Dual Arch</deviceDescription><DMExempt>true</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>+1(800)883-8733</phone><phoneExtension xsi:nil="true"/><email>sales@essix.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44728</gmdnCode><gmdnPTName>Dental shaded pontic kit</gmdnPTName><gmdnPTDefinition>A collection of devices intended to be used to produce artificial tooth veneers (shaded pontics) typically inside clear plastic custom-made teeth aligners (retainer-style orthodontic appliances). This is used to create the appearance of teeth inside the aligner to cover spaces where teeth may be missing for aesthetic purposes during treatment to realign teeth. The contents of the device may include polymer-based materials, dispenser gun, mixing tips, applicator brushes and practice aligner.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NXC</productCode><productCodeName>Aligner, sequential</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>