{"publicDeviceRecordKey":"4310c265-d32b-46f0-97f6-8facfdea90ed","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2022-06-30T00:00:00.000Z","devicePublishDate":"2022-06-22T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08809264293003","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"GUTTA PERCHA POINT 2%, N° 10","versionModelNumber":"24001","catalogNumber":null,"dunsNumber":"480420090","companyName":"Produits dentaires S.A.","deviceCount":1,"deviceDescription":"Gutta percha point is used to fill a prepared root canal prior to tooth restoration. It is used to fill the endodontic cavity to result in complete sealing in order to prevent reoccurrence of pathologies in root canal which may occur if root canal is not obturated.","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+41219212631","phoneExtension":null,"email":"info@pd-dental.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"31872","gmdnPTName":"Natural gutta-percha","gmdnPTDefinition":"A dental material made from coagulated sap of certain tropical trees intended to fill the root canal of a tooth. This material is softened by heat and inserted into the root canal, where it hardens as it cools. After application, this device cannot be reused.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EKM","productCodeName":"Gutta-Percha"}]},"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":[]}}