{"publicDeviceRecordKey":"40f2a1e1-71b1-40af-8cee-a733b6d323f2","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2025-10-09T00:00:00.000Z","devicePublishDate":"2016-09-03T00:00:00.000Z","deviceCommDistributionEndDate":"2016-11-01T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D7981BGS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Blue Gel Etchant","versionModelNumber":"1BGS","catalogNumber":"1BGS","dunsNumber":"113170088","companyName":"RELIANCE ORTHODONTIC PRODUCTS INC","deviceCount":1,"deviceDescription":"Blue Gel Etchant is intended for use in etching the tooth surface.  Product has high visibility blue color.  Product contains BAC (Benzalchromium chloride).  5 gm syringe.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"6307734009","phoneExtension":null,"email":"paulgropi@aol.com"}]},"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":"Store at room temperature (15-30 Degrees C)"}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}