<?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>9ba5049e-5149-440b-b717-6820fc481a9e</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2023-10-02</publicVersionDate><devicePublishDate>2023-09-22</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D76980400</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>IMTEC </brandName><versionModelNumber>8040</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>011441508</dunsNumber><companyName>PARK DENTAL RESEARCH CORP</companyName><deviceCount>1</deviceCount><deviceDescription>Torque Wrench (15-80 Ncm)</deviceDescription><DMExempt>true</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>1-800-243-7372</phone><phoneExtension xsi:nil="true"/><email>info@pdrus.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44901</gmdnCode><gmdnPTName>Dental torque wrench</gmdnPTName><gmdnPTDefinition>A hand-held dental tool intended for the manual application of rotation to tighten/loosen/remove a device [e.g., dental implant, spatial marker (localizer/tracker/calibrator)] fitted into or close to the oral cavity, and/or to a surgical instrument, in association with a dental surgical procedure [e.g., dental guided surgery registration]. It may have a built-in ratchet function, with forward and reverse direction, and a calibrated scale to which a recommended torque can be set; it is not a screwdriver. It is typically made of metallic or polymer materials and may have a standard socket connection to accommodate different tool bits/adaptors. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>DZN</productCode><productCodeName>Instruments, Dental Hand</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>