{"publicDeviceRecordKey":"090d64d3-7685-4b32-b481-55a65b7e3886","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-08-25T00:00:00.000Z","devicePublishDate":"2019-05-03T00:00:00.000Z","deviceCommDistributionEndDate":"2021-02-25T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D0405611","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Vericore ZR Pro ML","versionModelNumber":"74561","catalogNumber":"74561","dunsNumber":"006385173","companyName":"WHIP-MIX CORPORATION","deviceCount":1,"deviceDescription":"Vericore zirconia blanks are made from pre-sintered zirconium dioxide intended to be used with CAD/CAM or manual milling machines.  Vericore zirconia blanks are biocompatible and designed to fabricate;\n-\tZirconia Substructures\n-\tRestorations (Including inlays, onlays, and veneers)\n-\tCrown Framework in the Anterior and Posterior regions\n-\tBridge Framework in the Anterior and Posterior regions\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38594","gmdnPTName":"Custom-made dental crown, ceramic","gmdnPTDefinition":"A device made totally of ceramic material, and created for a specific post-pubescent/adult patient (custom-made), that functions as an artificial covering to replace the major part, or the whole part, of the clinical crown of a tooth.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIH","productCodeName":"Powder, Porcelain"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Width","size":{"unit":"Millimeter","value":"22"},"sizeText":null,"sizeString":"Width: 22 Millimeter"}]},"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":[]}}