{"publicDeviceRecordKey":"7aeab228-4da5-43dc-8a89-5270d01ceb99","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2024-10-16T00:00:00.000Z","devicePublishDate":"2024-10-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EPOLPMMAML4561","deviceIdType":"Package","deviceIdIssuingAgency":"HIBCC","containsDINumber":"EPOLPMMAML4560","pkgQuantity":1,"pkgDiscontinueDate":null,"pkgStatus":"In Commercial Distribution","pkgType":"carton box"},{"deviceId":"EPOLPMMAML4560","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PMMA CAD/CAM disc","versionModelNumber":"PMMAML.456","catalogNumber":"PMMAML.456","dunsNumber":"644778409","companyName":"POLIDENT d.o.o.","deviceCount":1,"deviceDescription":"PMMA CAD/CAM disc A1-15-95-Z MULTILAYER\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":"+38653304840","phoneExtension":null,"email":"polident@polident.si"}]},"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"},{"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"},{"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":[]}}