{"publicDeviceRecordKey":"277e0ae1-d064-4786-98c8-9f7559122ce8","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-21T00:00:00.000Z","devicePublishDate":"2023-06-13T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D02411333433","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"D0241133343","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box 144","versionModelNumber":"1133343","catalogNumber":"1133343","dunsNumber":"090735093","companyName":"Preventech","deviceCount":144,"deviceDescription":"PIVOT Plus Spiral Non-Latex Disposable Prophy Angle Soft Cup Box of 144 single use prophy angles for dental prophylaxis procedures","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"7048492416","phoneExtension":null,"email":"customerservice@preventech.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K951016","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"46938","gmdnPTName":"Dental polishing cup, single-use","gmdnPTDefinition":"A rotational device, typically made from rubber material, that is used to apply polishing agents during dental prophylaxis (cleaning). Commonly known as a prophylaxis cup it is held in a dental handpiece, which rotates the cup at high speeds as the polishing agent is applied to the surface of the teeth. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EHK","productCodeName":"Cup, Prophylaxis"}]},"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}