{"publicDeviceRecordKey":"c12f1761-2997-43d6-84cd-8cf105826b57","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-02-22T00:00:00.000Z","devicePublishDate":"2022-02-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D832XRFAS0","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"D832XRFAS1","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Plasdent","versionModelNumber":"XR-FAS","catalogNumber":"XR-FAS","dunsNumber":"190377184","companyName":"PLASDENT CORPORATION","deviceCount":25,"deviceDescription":"Complete Aligning System, 4 Arms, 4 Rings, 17 Bite Blocks \n","DMExempt":true,"premarketExempt":true,"deviceHCTP":false,"deviceKit":true,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":false,"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":[]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31828","gmdnPTName":"Dental x-ray system beam alignment device","gmdnPTDefinition":"A mechanical device that is used to support and position dental x-ray film and to serve as a guide for proper physical alignment of the x-ray tube with the positioned dental x-ray film during dental x-ray imaging procedures. Depending on the device design, it can be used as a guide for either intraoral or extraoral dental x-ray systems.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NRD","productCodeName":"Unit, Operative Dental, Accessories"}]},"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":[]}}