<?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>f2285b6b-5fea-4f76-bf7e-233745d2d872</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>2</publicVersionNumber><publicVersionDate>2024-01-30</publicVersionDate><devicePublishDate>2020-07-27</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D765RPM200PL0</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>RPM™ Reinforced PTFE Mesh</brandName><versionModelNumber>RPM200PL</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>123853058</dunsNumber><companyName>Osteogenics Biomedical Inc</companyName><deviceCount>1</deviceCount><deviceDescription>RPM™ Reinforced PTFE Mesh is a temporarily implantable material (non-resorbable) indicated for stabilization and support of bone grafts in alveolar bony defect sites.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>true</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>true</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>MR Conditional</MRISafetyStatus><rx>true</rx><otc>false</otc><contacts/><premarketSubmissions><premarketSubmission><submissionNumber>K171774</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>66253</gmdnCode><gmdnPTName>Dental/maxillofacial surgical mesh, metal/polymer</gmdnPTName><gmdnPTDefinition>A non-bioabsorbable, implantable, woven/knitted porous material made of both a synthetic polymer(s) and metal (typically a synthetic polymer covered metal frame) intended to provide temporary stabilization and support to a bone graft in the alveolar ridges, maxilla, or mandible. It is typically placed between the bone graft and soft tissue during dental or maxillofacial reconstruction and augmentation surgical procedures. Disposable devices associated with implantation may be supplied with the mesh.</gmdnPTDefinition><implantable>true</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>NPK</productCode><productCodeName>Barrier, Synthetic, Intraoral</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Millimeter" value="30"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Width</sizeType><size unit="Millimeter" value="25"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions><storageHandling><storageHandlingType>Storage Environment Temperature</storageHandlingType><storageHandlingHigh unit="Degrees Fahrenheit" value="86"/><storageHandlingLow unit="Degrees Fahrenheit" value="59"/><storageHandlingSpecialConditionText xsi:nil="true"/></storageHandling></environmentalConditions><sterilization><deviceSterile>true</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>