<?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>59b44f1c-ee66-49f4-9abe-324e119fc139</publicDeviceRecordKey><publicVersionStatus>New</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>1</publicVersionNumber><publicVersionDate>2025-05-22</publicVersionDate><devicePublishDate>2025-05-14</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D76980281</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>8028</versionModelNumber><catalogNumber>8028</catalogNumber><dunsNumber>011441508</dunsNumber><companyName>PARK DENTAL RESEARCH CORP</companyName><deviceCount>1</deviceCount><deviceDescription>Dispensing Gun</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>62514</gmdnCode><gmdnPTName>Syringe dispensing gun, reusable</gmdnPTName><gmdnPTDefinition>A hand-held, manually-operated device intended to facilitate the infusion/dispensing of a high viscosity fluid or pressurized liquid (e.g., laminar stream) by assisting with the advancement of the syringe plunger. It includes a manually-squeezed lever mechanism (e.g., pistol-like) and is designed to accept a standard syringe (not included) whereby it is intended to increase the amount of force the user can apply to the syringe plunger based on leverage. It is not foot-operated and does not include a rotating crank mechanism. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NDP</productCode><productCodeName>Accessories, Implant, Dental, Endosseous</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>