{"publicDeviceRecordKey":"687cc5ca-192f-4a17-b20c-5dcafd97d2f8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2018-09-10T00:00:00.000Z","devicePublishDate":"2018-08-10T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D798BILBPF0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Light Bond","versionModelNumber":"BILBPF","catalogNumber":"BILBPF","dunsNumber":"113170088","companyName":"RELIANCE ORTHODONTIC PRODUCTS INC","deviceCount":1,"deviceDescription":" Light Bond is intended for use as a light cure bracket and lingual retainer adhesive. \nLight Bond™ LIGHT CURE SEALANT AND BRACKET BONDING SYSTEM KIT  WITH  FLUORIDE \nPRODUCT FEATURES:\nSMOOTH, TACKY PASTE VISCOSITY: The viscosity of Light Bond™ Regular Paste is very tacky which\nhelps prevent bracket flotation. \nNO MIXING - UNLIMITED WORKING TIME: Light Bond™ is a photo initiated adhesive that offers the\noperator unlimited working time to position brackets and clean flash.\nBONDS TO METAL, CERAMIC \u0026 COMPOSITE SURFACES: Light Bond™ will bond to any enamel,\nporcelain, composite or metal surface, when properly conditioned.\nThis is the 2 syringe kit configuration","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":true,"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":"630-773-4009","phoneExtension":null,"email":"PAULGROPI@AOL.COM"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K895522","supplementNumber":"000"}]},"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":"Light Bond can be handled and stored at ambient temperatures"}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}