{"publicDeviceRecordKey":"4f435f2b-fa68-485b-b4f7-6755b42b4e3a","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-12-08T00:00:00.000Z","devicePublishDate":"2020-09-15T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EDDIDDCCOR1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"DD contrast color ","versionModelNumber":"orange","catalogNumber":"DDCCOR","dunsNumber":"313214171","companyName":"Dental Direkt GmbH","deviceCount":1,"deviceDescription":"The DD conrast® veneering ceramic system is suitable for the esthetic individualization of monolithic or minimally reduced dental crown and bridge constructions made of zirconium dioxide or lithium disilicate.","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":"K193588","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"16187","gmdnPTName":"Dental appliance fabrication material, ceramic","gmdnPTDefinition":"A dental material made of ceramic materials (e.g., zirconium oxide) intended to be used to manufacture a final dental prosthesis (e.g., a dental implant, removable dentures, crown, bridge) for patient use. It is used to create implantable and removable restorations using manual or computer-aided design/computer-aided manufacturing (CAD/CAM) technology. After application, this material cannot be reused for fabrication.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIH","productCodeName":"Powder, Porcelain"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Weight","size":{"unit":"Gram","value":"4"},"sizeText":null,"sizeString":"Weight: 4 Gram"}]},"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}