{"publicDeviceRecordKey":"43780dd4-4bfe-4714-aaf3-3884fb373b6f","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-03-22T00:00:00.000Z","devicePublishDate":"2022-03-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D818122011","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"ArgenZ HT+ 98x14 A2-L","versionModelNumber":"122011","catalogNumber":"122011","dunsNumber":"103095543","companyName":"ARGEN CORPORATION, THE","deviceCount":1,"deviceDescription":"Dental porcelain/ceramic restoration kit","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(858) 455-7900","phoneExtension":null,"email":"pcascone@argen.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K190079","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}