{"publicDeviceRecordKey":"213660b5-8810-4234-8675-984253bb1e14","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2026-04-03T00:00:00.000Z","devicePublishDate":"2026-03-26T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"J0036692001","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Densfil Plastic obturators ","versionModelNumber":"669200","catalogNumber":"669200","dunsNumber":"480538495","companyName":"MAILLEFER INSTRUMENTS HOLDING Sàrl","deviceCount":1,"deviceDescription":null,"DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"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":"47751","gmdnPTName":"Warm-bonded endodontic obturation system obturator","gmdnPTDefinition":"A hand-held manual dental instrument designed for direct warm bonding during an endodontic obturation procedure. It is preloaded (encased) with a resin-based sealing, filling, and core material at its distal working end which is subsequently heated in a dedicated oven to a specified temperature prior to delivery of the materials into a root canal. It is available in a variety of root canal sizes. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"EKM","productCodeName":"GUTTA-PERCHA"}]},"deviceSizes":{"deviceSize":[]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"up to 86°F"}]},"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":[]}}