<?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>70768626-81aa-4dab-b7ae-c167de7ad387</publicDeviceRecordKey><publicVersionStatus>Update</publicVersionStatus><deviceRecordStatus>Published</deviceRecordStatus><publicVersionNumber>4</publicVersionNumber><publicVersionDate>2025-10-09</publicVersionDate><devicePublishDate>2016-08-01</devicePublishDate><deviceCommDistributionEndDate xsi:nil="true"/><deviceCommDistributionStatus>In Commercial Distribution</deviceCommDistributionStatus><identifiers><identifier><deviceId>D798SEPD0</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>Self Etching Primer</brandName><versionModelNumber>SEPD</versionModelNumber><catalogNumber>SEPD</catalogNumber><dunsNumber>113170088</dunsNumber><companyName>RELIANCE ORTHODONTIC PRODUCTS INC</companyName><deviceCount>1</deviceCount><deviceDescription>The Reliance S.E.P.™ is a self etching primer dispenser is intended to be used for the delivery of the primer in preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.</deviceDescription><DMExempt>false</DMExempt><premarketExempt>false</premarketExempt><deviceHCTP>false</deviceHCTP><deviceKit>false</deviceKit><deviceCombinationProduct>false</deviceCombinationProduct><singleUse>false</singleUse><lotBatch>false</lotBatch><serialNumber>true</serialNumber><manufacturingDate>false</manufacturingDate><expirationDate>false</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><premarketSubmissions><premarketSubmission><submissionNumber>K071688</submissionNumber><supplementNumber>000</supplementNumber></premarketSubmission></premarketSubmissions><gmdnTerms><gmdn><gmdnCode>36153</gmdnCode><gmdnPTName>Dental tooth-etching solution</gmdnPTName><gmdnPTDefinition>An acid solution, in liquid or gel form, intended to be applied to tooth surfaces to create a retentive surface for a dental composite, adhesive, or a pit and fissure sealant; it is also referred to as dental etchant. 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 in ambient conditions</storageHandlingSpecialConditionText></storageHandling></environmentalConditions><sterilization><deviceSterile>false</deviceSterile><sterilizationPriorToUse>false</sterilizationPriorToUse><methodTypes/></sterilization></device>