<?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>989477bd-dba2-401a-b75b-6ccfaaa5a485</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2023-08-28</publicVersionDate><devicePublishDate>2020-07-23</devicePublishDate><deviceCommDistributionEndDate>2023-08-25</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D865REF00021</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>ClearCorrect System</brandName><versionModelNumber>Engager Template</versionModelNumber><catalogNumber>REF-02</catalogNumber><dunsNumber>016449078</dunsNumber><companyName>Clearcorrect Operating, LLC</companyName><deviceCount>1</deviceCount><deviceDescription>Engager template device accessory for use with the ClearCorrect System. </deviceDescription><DMExempt>false</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>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>888-331-3323</phone><phoneExtension xsi:nil="true"/><email>support@clearcorrect.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>65436</gmdnCode><gmdnPTName>Orthodontic resin positioning tray</gmdnPTName><gmdnPTDefinition>A custom-made dental device in the form of a patient’s dentition which contains cavities intended to hold and facilitate positioning of light-cured dental resin onto teeth for subsequent attachment of an orthodontic appliance (e.g. aligner) after curing. It is typically made of synthetic polymer materials and is manufactured from an orthodontic treatment plan based on an oral cavity impression or oral scan for a specific patient. This is a single-use device.</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>