{"publicDeviceRecordKey":"186a011f-53f0-4ec1-8756-3f7dd094f6d3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":5,"publicVersionDate":"2018-10-29T00:00:00.000Z","devicePublishDate":"2016-07-27T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D798SMCLB0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Crown Lok","versionModelNumber":"SMCLB","catalogNumber":"SMCLB","dunsNumber":"113170088","companyName":"RELIANCE ORTHODONTIC PRODUCTS INC","deviceCount":1,"deviceDescription":"Crown Lok™ is intended for use as a cement for metal crowns and orthodontic bands.  This is the Self Mixing dispensing in Blue Shade.","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":"630-773-4009","phoneExtension":null,"email":"paulgropi@aol.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38781","gmdnPTName":"Dental prosthesis veneer resin","gmdnPTDefinition":"A dental resin composite material intended to be used for veneering a restorative dental prosthesis (e.g., crown, bridge, fixed or removable denture); some types may be used as stains to apply colour to the dental appliance. After application, this material cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBF","productCodeName":"Material, Tooth Shade, 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":[]}}