<?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>40e221e3-c8f4-4ed8-ba06-8ea1dac6f1e9</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>M595D6400</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>Digitest™</brandName><versionModelNumber>D640</versionModelNumber><catalogNumber>D640</catalogNumber><dunsNumber>009900424</dunsNumber><companyName>PARKELL, INC.</companyName><deviceCount>1</deviceCount><deviceDescription>Digitest™ II Digital Pulptester</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>true</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>13187</gmdnCode><gmdnPTName>Dental pulp analysis system</gmdnPTName><gmdnPTDefinition>An assembly of devices designed to evaluate the pulpal vitality of teeth by electrically stimulating the nerve tissue of the pulp. The electric current needed to obtain a patient response to the stimulus is a measure of the condition of the dental pulp. The system typically includes a high frequency electronic oscillator, cables, and electrodes to apply the electrical signal; a display may be included. The system is used for determination of pulp necrosis, pulpitis, and involvement of teeth that approximate lesions (i.e., teeth that are next to diseased tissue).</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EAT</productCode><productCodeName>Tester, Pulp</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>