<?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>f6e04cdf-def5-4f3a-8bef-572ebbb72610</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2022-03-24</publicVersionDate><devicePublishDate>2022-01-08</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D9437819</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>Power Dental USA</brandName><versionModelNumber>7819</versionModelNumber><catalogNumber>7819</catalogNumber><dunsNumber>081305064</dunsNumber><companyName>Power Dental U.S.A. Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>DRILL GUIDE &amp; STOPPER SET (8 PCS)</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>true</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>true</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>+1(815)363-8003</phone><phoneExtension xsi:nil="true"/><email>info@mydentalusa.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>45147</gmdnCode><gmdnPTName>Dental/maxillofacial surgical procedure kit, non-medicated, reusable</gmdnPTName><gmdnPTDefinition>A collection of various dental/surgical instruments, dressings and the necessary materials intended to be used to perform a dental or oral/maxillofacial surgical procedure. It does not contain any pharmaceuticals. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>11791</gmdnCode><gmdnPTName>Dressing/utility forceps, scissors-like, reusable</gmdnPTName><gmdnPTDefinition>A hand-held manual instrument designed primarily for non-dedicated grasping of devices, sponges and/or dressings during a procedure; it is neither intended for tissue manipulation nor endoscopic use. It has a scissors-like hinged design with ring handles and blades (non-cutting) that may be available in a range of sizes or designs. It may be intended for use at a specific anatomy. This is a reusable device intended to be sterilized prior to use.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FTY</productCode><productCodeName>TAPE, MEASURING, RULERS AND CALIPERS</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>