{"publicDeviceRecordKey":"dcd3033f-0ccb-4cdd-b5c0-88e8a3e4b1fa","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2025-12-08T00:00:00.000Z","devicePublishDate":"2016-12-16T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EDDILAE15SO1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DD Art Elements","versionModelNumber":"SO","catalogNumber":"LAE15SO","dunsNumber":"313214171","companyName":"Dental Direkt GmbH","deviceCount":1,"deviceDescription":"DD Art Elements are universally applicable liquids for coloring and individualizing pre-sintered white zirconia constructions made from DD Bio Z, DD Bio ZX² or DD cubeX² zirconia milling blanks for the manufacture of dental restorations.","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+495225863190","phoneExtension":null,"email":"info@dentaldirekt.de"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K150196","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"62110","gmdnPTName":"Dental prosthesis dye","gmdnPTDefinition":"A colouring intended to be used to stain a dental prosthesis (e.g., crown, bridge) before insertion in the patient to achieve a colour to match existing dentition. It is a mixture of inorganic chemicals typically used during the prosthesis manufacturing process. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIH","productCodeName":"Powder, Porcelain"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Total Volume","size":{"unit":"Milliliter","value":"15"},"sizeText":null,"sizeString":"Total Volume: 15 Milliliter"}]},"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}