<?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>b0a1de8b-654b-4e50-9f17-16c4dfac33b8</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>6</publicVersionNumber><publicVersionDate>2026-05-29</publicVersionDate><devicePublishDate>2016-06-28</devicePublishDate><deviceCommDistributionEndDate>2026-05-21</deviceCommDistributionEndDate><deviceCommDistributionStatus>Not in Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D798AS0</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</brandName><versionModelNumber>AS</versionModelNumber><catalogNumber>AS</catalogNumber><dunsNumber>113170088</dunsNumber><companyName>RELIANCE ORTHODONTIC PRODUCTS INC</companyName><deviceCount>1</deviceCount><deviceDescription>Assure® Universal  Bonding  Resin  is  intended  to  increase adhesion  to  wet  or  dry,  normal  and  atypical  enamel  surfaces  including:    hypocalcified, 
fluorosed, deciduous enamel  and dentin.  It will  bond to  roughened metal  (amalgam, gold or stainless steel) and composite restorations without additional primers.  
PRODUCT  FEATURES: 
Assure® Universal  Bonding  Resin  is  hydrophilic  so  the  etched enamel  can  be  dry  or  slightly  contaminated  with  saliva. Assure® Universal  Bonding  Resin does not require light activation  (except on dentin). It can be used under any chemical, light cure or dual cure paste, regardless of manufacturer.</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>630-773-4009</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>Assure Universal Bonding Resin can be stored and handled at ambient temperatures</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>