<?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>db459867-b151-429b-a067-f7d94865d527</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2025-05-22</publicVersionDate><devicePublishDate>2025-02-19</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D690890170</deviceId><deviceIdType>Unit of Use</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><identifier><deviceId>D690890172</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>JAZZ POLISHER</brandName><versionModelNumber>U89017</versionModelNumber><catalogNumber>89017</catalogNumber><dunsNumber>151760014</dunsNumber><companyName>Ss White Burs, Inc.</companyName><deviceCount>20</deviceCount><deviceDescription>JAZZ RA PORCELAIN POLISHER 2 STEP P2S MEDIUM FLAME - 20 PACK</deviceDescription><DMExempt>true</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+1(732)905-1100</phone><phoneExtension xsi:nil="true"/><email>customerservice@sswhitedental.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>63517</gmdnCode><gmdnPTName>Dental abrasive point, single-use</gmdnPTName><gmdnPTDefinition>A sterile rotary endpiece designed to be attached to a dental power tool handpiece to perform a specific rotating mechanical function during a dental or orthodontic procedure, typically for polishing and smoothing natural or restorative dental materials (e.g., to finish a crown). Also referred to as a polisher, it is available in various forms [e.g., conical] and sizes and is made of synthetic polymer materials (e.g., silicone, rubber). This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EHL</productCode><productCodeName>POINT, ABRASIVE</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>