<?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>05420c31-b03d-4b6e-9450-34eaee68d321</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2021-06-28</publicVersionDate><devicePublishDate>2021-06-07</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>08806387805144</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>Gutta Percha 06-LM-20</brandName><versionModelNumber>0514</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>688322841</dunsNumber><companyName>Meta Biomed Co., Ltd.</companyName><deviceCount>1</deviceCount><deviceDescription>Gutta Percha Points and Bars Length Marked 06 taper #20, 60Points, P71</deviceDescription><DMExempt>false</DMExempt><premarketExempt>true</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>true</manufacturingDate><expirationDate>true</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>45081</gmdnCode><gmdnPTName>Synthetic gutta-percha</gmdnPTName><gmdnPTDefinition>A dental material made from a polymer-based, synthetic gutta-percha containing fillers and radiopacifiers in a soft resin matrix, intended to fill the root canal of a tooth. This material has the ability to resist leakage significantly better than natural gutta-percha based obturation whilst strengthening the root resulting in roots having a coronal and apical seal as part of the canal filling process. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EKM</productCode><productCodeName>Gutta-Percha</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>