{"publicDeviceRecordKey":"76be6b8c-48d8-401c-a4ee-63e228d2881e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2021-10-29T00:00:00.000Z","devicePublishDate":"2016-08-31T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"E22125071","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Structur 3","versionModelNumber":"2507","catalogNumber":"2507","dunsNumber":"316699578","companyName":"VOCO GmbH","deviceCount":1,"deviceDescription":"Self-curing composite material for the fabrication of provisional crowns and bridges.","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":"999-999-9999","phoneExtension":null,"email":"xxx@xx.xx"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K120779","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31783","gmdnPTName":"Temporary dental crown/bridge","gmdnPTDefinition":"A prosthetic dental device intended to temporarily replace the top of a tooth or a group of teeth until a permanent restoration is fabricated. The device is typically made of plastic material [e.g., polymethylmethacrylate (PMMA)].","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EBG","productCodeName":"Crown And Bridge, Temporary, Resin"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Storage Environment Temperature","storageHandlingHigh":{"unit":"Degrees Celsius","value":"23"},"storageHandlingLow":{"unit":"Degrees Celsius","value":"4"},"storageHandlingSpecialConditionText":null}]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}