{"publicDeviceRecordKey":"a38eac4e-8339-4e6a-a89a-ca5aee0b9682","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2024-02-16T00:00:00.000Z","devicePublishDate":"2016-08-17T00:00:00.000Z","deviceCommDistributionEndDate":"2019-05-08T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D798LBEMTFWAS0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Light Bond","versionModelNumber":"LBEMTF W/AS","catalogNumber":"LBEMTF W/AS","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.  Light Bond™ will bond to any enamel,\nporcelain, composite or metal surface, when properly conditioned.  \nThis is the Light Bond Medium Viscosity Kit with Assure Bonding Resin.  This product contains fluoride.\nThis kit includes 4 X 5g Light Bond Medium Paste in tips, 1 X 6cc Assure Bonding Resin, 1 X 23g Etchant and mixing accessories. ","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":"6307734009","phoneExtension":null,"email":"paulgropi@aol.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"34782","gmdnPTName":"Dentine bonding agent/set","gmdnPTDefinition":"A material(s) primarily intended to be used as a bonding-promoting substance between dentine and a dental composite filling, restorative, or luting material; it may also be used as an enamel bonding material. It includes a resin-based bonding agent and may also include a primer, etching solution or curing activator, within the same formulation, or as part of a set. It is not a primer, etching solution and/or activator sold in the absence of a bonding agent; composite resin is not included. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"},{"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"},{"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) Avoid excessive heat. "}]},"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":[]}}