{"publicDeviceRecordKey":"428a81a5-e75e-4f4b-84d9-8d1e19bbc7cc","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":"EMICTPS21","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Temp Silicon Brush","versionModelNumber":"TPS2","catalogNumber":"TPS2","dunsNumber":"436661136","companyName":"MICERIUM SPA","deviceCount":1,"deviceDescription":"Temp Silicon Brush\nSilicon Brushes for composite application\nBrush tips, white small 5pcs Temp Silicon Brush\nINTRODUCTORY KIT TEMP BRUSHES white small soft\n5 S2 bruhes Temp with silicon tip for the modellation of composite.\nKit composed by:\nn5  SS2 – S2 silicon tip long spatula shape for blending layers and shaping surfaces.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"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":[]}}