{"publicDeviceRecordKey":"3dc8b2ad-6b74-470e-b4f3-5ecd4f6ae279","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2018-03-29T00:00:00.000Z","devicePublishDate":"2016-09-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D83600490","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Light Super Bond-M-L/C Orthodontic Adhesive Single Syringe ","versionModelNumber":"0049","catalogNumber":"0049","dunsNumber":"789664455","companyName":"DENT ZAR, INC.","deviceCount":1,"deviceDescription":"Light Super Bond represents state-of- the-art technology: it offers the most desirable characteristics, in versatility, ease of handling and reliability. \n•\tUnlimited working time-cures on demand with a visible light-curing unit.\n•\tBracket compatibility-designed to be used with ceramic, plastic or metal brackets.\n•\tViscosity-consistency of the Light Super Bond-M paste eliminates bracket flotation.\n•\t High light sensitivity of the material allows for the use of Light Super Bond-M not only for bonding translucent (plastic or ceramic) brackets, but also for light impermeable metal ones.\n•\tLight Super Bond-M is a light cured material, which allows for relief from time pressure.\n•\tThe dentist, therefore, has plenty of time for cleaning the excess adhesive around the bracket bases. \n•\tSimplicity of application procedure, and relief from time pressure, results in obtaining reproducible bond strength, and precise bracket placement.\n•\tThe material has superior resistance to discoloration. It is economical to use and has virtually no waste and long shelf life, all of which contribute to the ease of working with this product.\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":true,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"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":[]},"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":[]}}