<?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>233bd5b2-24e4-431b-9b29-e82496966f88</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2021-08-18</publicVersionDate><devicePublishDate>2017-02-10</devicePublishDate><deviceCommDistributionEndDate>2021-08-18</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D6585550171</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>The Ultimate F &amp; P Kit</brandName><versionModelNumber>555017</versionModelNumber><catalogNumber>555017</catalogNumber><dunsNumber>005473608</dunsNumber><companyName>Gc America Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>The Ultimate F &amp; P Kit refill pack, 12-bladed, flame tip (sm)</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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(708)597-0900</phone><phoneExtension xsi:nil="true"/><email>customerservice@gcamerica.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>35170</gmdnCode><gmdnPTName>Dental mandrel</gmdnPTName><gmdnPTDefinition>A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EJQ</productCode><productCodeName>WHEEL, POLISHING AGENT</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>