{"publicDeviceRecordKey":"8812c655-d67c-4452-b0c0-7e89dd20a1ec","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":"D02411001533","deviceIdType":"Unit of Use","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null},{"deviceId":"D0241100153","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"PIVOT Nada Pumice Paste Prophy Pack Box 100","versionModelNumber":"1100153","catalogNumber":"1100153","dunsNumber":"090735093","companyName":"Preventech","deviceCount":100,"deviceDescription":"PIVOT Nada Pumice Paste Prophy Pack Box of 100 units each containing 1 PIVOT Non-Latex Prophy Angle Soft Cup and 1 2.0g prophy cup of NADA Pumice Prophy Paste","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":"K100539","supplementNumber":"000"},{"submissionNumber":"K951016","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"11168","gmdnPTName":"Dentifrice","gmdnPTDefinition":"A substance, or combination of substances, intended to be used for cleaning the accessible surfaces of the teeth by polishing. It typically includes mild abrasives, detergents, flavouring agents, and other products, and is normally supplied as a toothpaste or tooth powder intended for self-application using a toothbrush, or formulated to be applied by dental professionals using a handpiece attachment. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"},{"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"},{"productCode":"EJR","productCodeName":"Agent, Polishing, Abrasive, Oral Cavity"}]},"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}