<?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>4f539145-4235-44bc-94df-a4d41cba794d</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-10-13</publicVersionDate><devicePublishDate>2023-10-05</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>10840326420246</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber>00840326420249</containsDINumber><pkgQuantity>1</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType>Inner Pack</pkgType></identifier><identifier><deviceId>00840326420249</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>Plak Smacker</brandName><versionModelNumber>545-06616</versionModelNumber><catalogNumber>545-06616</catalogNumber><dunsNumber>004193103</dunsNumber><companyName>Young Innovations, Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>Elastic Power Chain, Short, 15&apos;, Lilac</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>+1 (800) 558-6684</phone><phoneExtension xsi:nil="true"/><email>support@youngspecialties.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>41677</gmdnCode><gmdnPTName>Orthodontic archwire/bracket ligature</gmdnPTName><gmdnPTDefinition>A device intended to securely tether an orthodontic archwire to an orthodontic bracket, or securely hold the archwire in the archwire slot of an orthodontic bracket (or brace). It is in the form of a small single tie, or a circular band made of elastomeric (e.g., polyurethane, rubber) or metal materials. This is a single-patient device intended to be replaced regularly during orthodontic treatment (single-use).</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ECI</productCode><productCodeName>BAND, ELASTIC, ORTHODONTIC</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>