{"publicDeviceRecordKey":"4073fa38-3d34-44df-a5d9-6786ff6c6e4f","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-08-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E22112411","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Final Varnish LC","versionModelNumber":"1241","catalogNumber":"1241","dunsNumber":"316699578","companyName":"VOCO GmbH","deviceCount":1,"deviceDescription":"Light-curing varnish for glass ionomer materials","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":"999-999-9999","phoneExtension":null,"email":"xxx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K030844","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45294","gmdnPTName":"Dental restorative material varnish","gmdnPTDefinition":"A liquid substance used to cover dental filling material in the initial setting period after application typically to prevent moisture infiltration (especially when a dental silicate or glass ionomer cement is used as a filling material). The device typically consists of dissolved artificial resins. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"KLE","productCodeName":"Agent, Tooth Bonding, Resin"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"23"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"4"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}