<?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>a8425813-91da-4508-bb1d-885127087ffb</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2023-10-30</publicVersionDate><devicePublishDate>2021-05-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D746ACWR1</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>Chewies ™</brandName><versionModelNumber>AC-W-R</versionModelNumber><catalogNumber>AC-W-R</catalogNumber><dunsNumber>116903307</dunsNumber><companyName>DENTSPLY SIRONA ORTHODONTICS INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Chewies (TM) Aligner Tray Seaters - Single     White-Retail</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</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>63676</gmdnCode><gmdnPTName>Orthodontic aligner/retainer seater, single-use</gmdnPTName><gmdnPTDefinition>A small cylindrical pledget intended to be used to facilitate placement and proper seating of an orthodontic progressive aligner or teeth retainer (positioner), by being placed between the partially-aligned aligner/retainer and the opposing set of teeth, allowing the patient to bite down on the device to push the aligner/retainer into place. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ECS</productCode><productCodeName>PUSHER, BAND, ORTHODONTIC</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>