<?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>075f11e9-2dcc-48fe-99da-986bf3cff9d2</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2021-04-22</publicVersionDate><devicePublishDate>2020-03-02</devicePublishDate><deviceCommDistributionEndDate>2021-04-21</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08809455600528</deviceId><deviceIdType>Primary</deviceIdType><deviceIdIssuingAgency>GS1</deviceIdIssuingAgency><containsDINumber xsi:nil="true"/><pkgQuantity xsi:nil="true"/><pkgDiscontinueDate xsi:nil="true"/><pkgStatus xsi:nil="true"/><pkgType xsi:nil="true"/></identifier></identifiers><brandName>EQ-V</brandName><versionModelNumber>EQV-P25</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>687503532</dunsNumber><companyName>META SYSTEMS CO., LTD.</companyName><deviceCount>1</deviceCount><deviceDescription>Pack tip (50/04, 60/05)</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>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><gmdnTerms><gmdn><gmdnCode>45247</gmdnCode><gmdnPTName>Endodontic obturation system</gmdnPTName><gmdnPTDefinition>An assembly of devices intended to be used during endodontic treatment involving root canal obturation procedures. It may be used in a variety of modes, e.g., to provide continuous heat to the tip of a dental instrument to test tooth response to thermal stimulus, for tissue cauterization and coagulation, and to backfill and down pack gutta-percha during endodontic root canal treatment or root canal obturation. It typically consists of a mains electricity (AC-powered) generator that regulates an electrical current used to produce resistive heat via the handpieces for the application of the heat, or extrude gutta-percha during a root canal obturation.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EKR</productCode><productCodeName>Plugger, Root Canal, Endodontic</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>true</sterilizationPriorToUse><methodTypes><sterilizationMethod>Moist Heat or Steam Sterilization</sterilizationMethod></methodTypes></sterilization></device>