<?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>05a11967-c9f6-46dd-891f-538869eef5d1</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2022-05-16</publicVersionDate><devicePublishDate>2021-06-20</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D9436932</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>6932</versionModelNumber><catalogNumber>6932</catalogNumber><dunsNumber>081305064</dunsNumber><companyName>Power Dental U.S.A. Inc.</companyName><deviceCount>1</deviceCount><deviceDescription>PARA MIRROR POSTERIOR 5mm MEASUREMENT LINE STAINLESS</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</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>33209</gmdnCode><gmdnPTName>Orthodontic pliers</gmdnPTName><gmdnPTDefinition>A hand-held manual dental instrument designed to hold small objects or to bend or to cut metal strips or wire used in orthodontic procedures. It is typically made of high-grade steel and consists of two arms/rods that form a handle proximally and extend distally through a pivot point to terminate with jaws available in various shapes depending on intended use. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn><gmdn><gmdnCode>47015</gmdnCode><gmdnPTName>Dental ultrasonic surgical system handpiece tip</gmdnPTName><gmdnPTDefinition>A removable endpiece intended to be attached to a dental ultrasonic surgical system handpiece, and makes contact with a patient while oscillating (vibrating) at high frequency in order to mechanically fragment and cut bone during dental surgery. The device is available in a variety of forms (e.g., flat serrated blade, ball head, nail head, or probe-like) and sizes, and is typically made of metal; it is not intended to be held directly (i.e., does not include a holder). It is used for implant site preparation, dental extraction, distraction, sinus lift, periodontal surgery, cyst removal, extraction of bone block, bone harvesting, osteoplasty, and osteotomy. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>FTX</productCode><productCodeName>MIRROR, GENERAL &amp; PLASTIC SURGERY</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>