<?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>837bf426-83ff-44fb-88d7-8bfae15f9a5a</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2019-04-01</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate>2019-01-01</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>M595D8450</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>NA</brandName><versionModelNumber>D845</versionModelNumber><catalogNumber>D845</catalogNumber><dunsNumber>009900424</dunsNumber><companyName>PARKELL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Autoclavable Handpiece Sheath with Dental-Ez Logo</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts><customerContact><phone>6312491134</phone><phoneExtension xsi:nil="true"/><email>customerservice@parkell.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>44907</gmdnCode><gmdnPTName>Ultrasonic dental scaling/debridement system handpiece</gmdnPTName><gmdnPTDefinition>A hand-held component of an ultrasonic dental debridement system intended to convert high frequency electrical current from a generator into an ultrasonic oscillation, for a tip placed at its end to mechanically fragment and dislodge gross debris/accretions during an endodontic and/or periodontal procedure. It may also serve as a conduit for fluid intended to prevent overheating of the tip and surrounding tissue. This device is typically in the form of a pen/pencil with attached cables. This is a reusable device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>ELC</productCode><productCodeName>Scaler, Ultrasonic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>