{"publicDeviceRecordKey":"1755205d-f1ee-433f-8757-ce411de66cd9","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2021-08-18T00:00:00.000Z","devicePublishDate":"2017-02-10T00:00:00.000Z","deviceCommDistributionEndDate":"2021-08-18T00:00:00.000Z","deviceCommDistributionStatus":"Not in Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D6585550141","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"The Ultimate F \u0026 P Kit","versionModelNumber":"555014","catalogNumber":"555014","dunsNumber":"005473608","companyName":"Gc America Inc.","deviceCount":1,"deviceDescription":"The Ultimate F \u0026 P kit refill pack, 12-bladed, flame tip (sm)","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(708)597-0900","phoneExtension":null,"email":"customerservice@gcamerica.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"35170","gmdnPTName":"Dental mandrel","gmdnPTDefinition":"A slender, round, metal shaft designed to be used chairside to hold (locked into place) a rotating dental device, e.g., a grinding wheel, abrasive disk, circular saw, or a disk, stone or cup used for grinding or polishing. The mandrel will be placed into a dental handpiece that will rotate at high speed. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EJQ","productCodeName":"WHEEL, POLISHING AGENT"}]},"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":[]}}