<?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>21416323-f727-4f66-84b8-040e23a089a9</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2026-05-29</publicVersionDate><devicePublishDate>2016-07-13</devicePublishDate><deviceCommDistributionEndDate>2026-05-13</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D798PLUS0</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> Assure Plus All Surface Bonding Resin</brandName><versionModelNumber>PLUS</versionModelNumber><catalogNumber>PLUS</catalogNumber><dunsNumber>113170088</dunsNumber><companyName>RELIANCE ORTHODONTIC PRODUCTS INC</companyName><deviceCount>1</deviceCount><deviceDescription>Assure® Plus All Surface Bonding Resin is intended to increase adhesion to normal, atypical (wet or dry) enamel surfaces including: hypocalcified, fluorosed, deciduous enamel and dentin. It will bond to roughened metal (amalgam, gold or stainless steel), porcelain, zirconia, composite restorations, acrylic temporary/pontic teeth. 
Assure®Plus All Surface Bonding Resin is hydrophilic so the etched enamel can be dry or slightly contaminated with saliva. It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer.  6 ml bottle size</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>true</lotBatch><serialNumber>false</serialNumber><manufacturingDate>false</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><customerContact><phone>6307734009</phone><phoneExtension xsi:nil="true"/><email>paulgropi@aol.com</email></customerContact></contacts><gmdnTerms><gmdn><gmdnCode>34782</gmdnCode><gmdnPTName>Dentine bonding agent/set</gmdnPTName><gmdnPTDefinition>A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.</gmdnPTDefinition><implantable>false</implantable><gmdnCodeStatus>Active</gmdnCodeStatus></gmdn></gmdnTerms><productCodes><fdaProductCode><productCode>KLE</productCode><productCodeName>Agent, Tooth Bonding, Resin</productCodeName></fdaProductCode></productCodes><deviceSizes/><environmentalConditions><storageHandling><storageHandlingType>Special Storage Condition, Specify</storageHandlingType><storageHandlingHigh unit="" value=""/><storageHandlingLow unit="" value=""/><storageHandlingSpecialConditionText>Store at room temperature (15-30 Degrees C). Protect from heat and light.  Avoid evaporation. </storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>