{"publicDeviceRecordKey":"289ec8fd-c88f-441b-8f9d-322c26030db8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-10-09T00:00:00.000Z","devicePublishDate":"2016-08-01T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D798SEPPRO0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Self Etching primer","versionModelNumber":"SEPPRO","catalogNumber":"SEPPRO","dunsNumber":"113170088","companyName":"RELIANCE ORTHODONTIC PRODUCTS INC","deviceCount":1,"deviceDescription":"The Reliance S.E.P.™ is a self etching primer Kit  intended to be used for the preparation of an enamel surface of a tooth prior to bonding with a light cure orthodontic adhesive.S.E.P Starter Kit – Ref# SEPPROS.E.P. Refill Cartridge -Ref# SEPR Light Impervious Mixing Well – Ref# SEPW Microbrushes -Ref# MB S.E.P Dispenser -Ref# SEPD","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"630-773-4009","phoneExtension":null,"email":"paulgropi@aol.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K071688","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"36153","gmdnPTName":"Dental tooth-etching solution","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.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KLE","productCodeName":"Agent, Tooth Bonding, Resin"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"TEMPERATURE LIMITATIONS: Store refill cartridges refrigerated (2-8 Degrees C).  Do not freeze.Allow product to reach room temperature prior to use.Avoid exposure to light."}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}