{"publicDeviceRecordKey":"6aa8a5c4-a60f-4989-b24b-8de2a5e835ed","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-12-03T00:00:00.000Z","devicePublishDate":"2019-11-25T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EMICSS50","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Temp Silicon Brush","versionModelNumber":"SS5","catalogNumber":"SS5","dunsNumber":"436661136","companyName":"MICERIUM SPA","deviceCount":1,"deviceDescription":"Temp Silicon Brush\nSilicon Brushes for composite application\nS5 silicon tip with three sides for stains and characterizations.\n","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"63953","gmdnPTName":"Dental material application tool, reusable","gmdnPTDefinition":"A hand-held manual dental instrument intended to be used for the application of a dental material (e.g., composite resin) to a dental prosthesis or to a patient’s tooth/teeth; the material is not included. It includes a handle with an application tip which holds the material on its surface; it is not a syringe- or pistol-like device. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EJB","productCodeName":"Handle, Instrument, Dental"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Centimeter","value":"14.7"},"sizeText":null,"sizeString":"Length: 14.7 Centimeter"}]},"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":[]}}