<?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>579312cd-3742-4ea2-9ae4-ab3230ed96eb</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>3</publicVersionNumber><publicVersionDate>2018-07-06</publicVersionDate><devicePublishDate>2016-09-23</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D758XK1</deviceId><deviceIdType>Package</deviceIdType><deviceIdIssuingAgency>HIBCC</deviceIdIssuingAgency><containsDINumber>D758XK0</containsDINumber><pkgQuantity>3</pkgQuantity><pkgDiscontinueDate xsi:nil="true"/><pkgStatus>In Commercial Distribution</pkgStatus><pkgType xsi:nil="true"/></identifier><identifier><deviceId>D758XK0</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>Ribbond Bondable Reinfocement Ribbond Kit</brandName><versionModelNumber>Triaxial</versionModelNumber><catalogNumber xsi:nil="true"/><dunsNumber>796596989</dunsNumber><companyName>RIBBOND, INC</companyName><deviceCount>1</deviceCount><deviceDescription>Dental fiber reinforcement Kit Triaxial</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>true</manufacturingDate><expirationDate>false</expirationDate><donationIdNumber>false</donationIdNumber><labeledContainsNRL>false</labeledContainsNRL><labeledNoNRL>false</labeledNoNRL><MRISafetyStatus>Labeling does not contain MRI Safety Information</MRISafetyStatus><rx>false</rx><otc>false</otc><contacts><customerContact><phone>2063408870</phone><phoneExtension xsi:nil="true"/><email>ribbond@ribbond.com</email></customerContact></contacts><premarketSubmissions><premarketSubmission><submissionNumber>K013881</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>44786</gmdnCode><gmdnPTName>Dental reinforcing fibre</gmdnPTName><gmdnPTDefinition>A device used in general restorative dentistry and orthodontic treatment typically as reinforcement of dental polymer-based materials, used for the construction of dental prostheses, i.e., splints, posts, crowns, and bridges. This device is typically made of polyethylene (PE) fibres supplied in strands, braid, or ribbon in a variety of sizes. It may also be used for the stabilization of avulsed teeth maintaining diastema closures or split-tooth syndrome. The ultrahigh molecular weight PE fibres increase the strength of composite materials, and provide improved safety by assisting in the retention of pieces in the event that a dental prosthesis is broken. This is a single-use device.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>EBI</productCode><productCodeName>Resin, Denture, Relining, Repairing, Rebasing</productCodeName></fdaProductCode></productCodes><deviceSizes><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="22"/><sizeText xsi:nil="true"/></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Dense</sizeText></deviceSize><deviceSize><sizeType>Device Size Text, specify</sizeType><size unit="" value=""/><sizeText>Thin</sizeText></deviceSize><deviceSize><sizeType>Length</sizeType><size unit="Centimeter" value="15"/><sizeText xsi:nil="true"/></deviceSize></deviceSizes><environmentalConditions/><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>