{"publicDeviceRecordKey":"ed87c4f1-6f24-4bee-ac42-82bfea1d95be","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2021-02-11T00:00:00.000Z","devicePublishDate":"2021-02-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E235P03410","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"VINTAGE PRO ENAM EFFECT DC-T 1","versionModelNumber":"P0341","catalogNumber":"P0341","dunsNumber":"054618202","companyName":"SHOFU DENTAL CORPORATION","deviceCount":1,"deviceDescription":"VINTAGE PRO ENAM EFFECT DC-T 1","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":"+1(800)827-5262","phoneExtension":null,"email":"customer-service@shofu.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K181496","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44727","gmdnPTName":"Dental porcelain/ceramic restoration kit","gmdnPTDefinition":"A collection of containers with different shades of porcelain (ceramic based material in powder form) intended to be used in prefabricated and custom-made dental restorations, e.g., artificial teeth on copings, crowns, or bridges. This kit is typically used in the dental laboratory. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIH","productCodeName":"POWDER, PORCELAIN"}]},"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}