{"publicDeviceRecordKey":"65a9835d-1be3-48c5-a6c6-6ab0db28bf64","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2019-10-02T00:00:00.000Z","devicePublishDate":"2019-09-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08056640034075","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"SUPER LUX A1-D4 X8 LOWER A1-1/65","versionModelNumber":"Shade A1, Mould 1/65","catalogNumber":"T3012","dunsNumber":"459034567","companyName":"MAJOR PRODOTTI DENTARI SPA","deviceCount":1,"deviceDescription":"SUPER LUX A1-D4 , EIGHT ARTIFICIAL TEETH, LOWER, SHADE A1, MOULD 1/65","DMExempt":true,"premarketExempt":true,"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":false,"otc":false,"contacts":{"customerContact":[{"phone":"+390116400211","phoneExtension":null,"email":"monica.funai@majordental.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"38643","gmdnPTName":"Resin artificial teeth","gmdnPTDefinition":"Prefabricated teeth made of polymer-based material for mounting on dentures. Teeth are normally delivered as sets of front teeth, upper or lower jaw, or sets of premolars and molars, upper or lower jaw, in various sizes, shapes and colours.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"ELM","productCodeName":"Denture, Plastic, Teeth"}]},"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,"premarketSubmissions":{"premarketSubmission":[]}}