{"publicDeviceRecordKey":"6b4f9127-8036-4aa8-a8a2-2a493b8ee5d6","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-14T00:00:00.000Z","devicePublishDate":"2023-06-06T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D832PSRM0","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Plasdent","versionModelNumber":"PSR-M","catalogNumber":"PSR-M","dunsNumber":"190377184","companyName":"PLASDENT CORPORATION","deviceCount":1,"deviceDescription":"Polishing Strip Roll, 1/8\"W X 19'L, Medium","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"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":"35702","gmdnPTName":"Dental abrasive strip, single-use","gmdnPTDefinition":"A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.","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":[]}}