{"publicDeviceRecordKey":"3c7c38f2-e778-4557-afbd-c7a69ba7126e","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2019-01-23T00:00:00.000Z","devicePublishDate":"2016-11-08T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D800FMAA2002","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Stabilizer (50 ml)","versionModelNumber":"FMAA2002","catalogNumber":null,"dunsNumber":"564251911","companyName":"ZIRKONZAHN SRL","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"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":"+390474066660","phoneExtension":null,"email":"info@zirkonzahn.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"17844","gmdnPTName":"Dental articulation paste/solution","gmdnPTDefinition":"A substance intended to characterize the contact relationship between the maxillary and the mandibular teeth during occlusion, and between interproximal surfaces, to help determine the proper seating of full or partial dentures, crowns and bridges, and to program and/or assess progress of orthodontic treatment. It may include one or more substances (e.g., wetting spray, silicone paste, drying liquid that turns into a removable film) and is designed to be applied to the teeth or a restorative prosthesis to show the contact surfaces in situ or on a substrate (e.g., impression material) that displays visible marks when the patient bites. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EIH","productCodeName":"POWDER, PORCELAIN"}]},"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":[]}}