{"publicDeviceRecordKey":"76859161-6625-41ec-ac61-b7f6c7b4ce24","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2022-05-13T00:00:00.000Z","devicePublishDate":"2016-08-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D798LCR150","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Light Cure Retainer","versionModelNumber":"LCR15","catalogNumber":"LCR15","dunsNumber":"113170088","companyName":"RELIANCE ORTHODONTIC PRODUCTS INC","deviceCount":1,"deviceDescription":"L.C.R™is a flowable, light cure orthodontic adhesive intended to be used within an orthodontic, dental or pediatric dental office for the bonding of lingual retainers, creation of occlusal buildups and for retention of thermoplastic aligners.\nThis product contains 1.5g of LCR in a push syringe dispenser.  ","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":"regulatory@relianceorthodontics.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31750","gmdnPTName":"Orthodontic bracket adhesive","gmdnPTDefinition":"A bonding compound, e.g., polymethylmethacrylate (PMMA), used specifically to cement an orthodontic bracket to the surface of a tooth. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DYH","productCodeName":"Adhesive, Bracket And Tooth Conditioner, 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":[]}}