{"publicDeviceRecordKey":"e200e77b-2afa-402c-af9a-24bc61c3d5e8","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":4,"publicVersionDate":"2018-12-07T00:00:00.000Z","devicePublishDate":"2016-10-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08809162702201","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Implantium, Superline","versionModelNumber":"HAB654070L","catalogNumber":"HAB654070L","dunsNumber":"689514395","companyName":"Dentium Co., Ltd.","deviceCount":1,"deviceDescription":"Endosseous dental implant abutment","DMExempt":true,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":true,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(714)226-0229","phoneExtension":null,"email":"cs@dentiumusa.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K052957","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44880","gmdnPTName":"Dental implant suprastructure, temporary, preformed, single-use","gmdnPTDefinition":"A prefabricated device intended to be used during dental implant restorative and laboratory procedures to provide a temporary intermediate fixture level between a dental implant and a temporary dental prosthesis/restoration, during the oral soft-tissue healing and sculpturing period, prior to the fabrication/rehabilitation and installation of the final prosthesis/restoration (e.g., bridge, single tooth, overdenture). It typically includes burnout/temporary cylinders, fixture impression pick-ups, replica devices, caps/cover screws in a variety of shapes, sizes, and materials [e.g., titanium (Ti), plastic]. This is a single-use device.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NHA","productCodeName":"ABUTMENT, IMPLANT, DENTAL, ENDOSSEOUS"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"6.5"},"sizeText":null,"sizeString":"Outer Diameter: 6.5 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"14.655"},"sizeText":null,"sizeString":"Length: 14.655 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":false,"sterilizationPriorToUse":true,"methodTypes":{"sterilizationMethod":["Moist Heat or Steam Sterilization"]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}