<?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>1b46196d-2b86-4ae1-84cc-520bdc182413</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2022-06-30</publicVersionDate><devicePublishDate>2022-06-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>J01020362</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>GATES-GLIDDEN DRILLS RA, N°1-6</brandName><versionModelNumber>20362</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>480420090</dunsNumber><companyName>Produits dentaires S.A.</companyName><deviceCount>1</deviceCount><deviceDescription>Rack of 6 - 32 mm length 
Different Diam 0.50 / 0.70 / 0.90 / 1.10 / 1.30 / 1.50
Gates Glidden are mechanized dental instruments used for accessing to the root canal and enlarging the opening of the coronal part of the root canal, before and after using files. Gates-Glidden are also used for pin or post hole preparation.</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>true</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>+41219212631</phone><phoneExtension xsi:nil="true"/><email>info@pd-dental.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>31876</gmdnCode><gmdnPTName>Endodontic enlarger, reusable</gmdnPTName><gmdnPTDefinition>A manual dental instrument designed to be used to access the root canal and to enlarge the opening of the coronal portion of the root canal. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EKQ</productCode><productCodeName>Preparer, Root Canal Endodontic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>