{"publicDeviceRecordKey":"ab2a794a-06e0-43fb-9411-7015703670dc","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":2,"publicVersionDate":"2025-02-13T00:00:00.000Z","devicePublishDate":"2022-07-14T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"08435451614469","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"KLOCKNER","versionModelNumber":"SG-9010","catalogNumber":"SG-9010","dunsNumber":"464517122","companyName":"SOADCO, S.L.","deviceCount":1,"deviceDescription":"SK2 5° HEXAGONAL TRUNCOCONICAL ABUTMENT [Ø5.5MM-AT0.5]","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":true,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":false,"otc":false,"contacts":{"customerContact":[{"phone":"+376800593","phoneExtension":null,"email":"calidad@soadco.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K010132","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"44881","gmdnPTName":"Dental implant suprastructure kit","gmdnPTDefinition":"A collection of prefabricated dental devices and components used to create a suprastructure on a dental implant to mimic preparations of natural teeth. It is used during dental implant restorative and laboratory procedures and will typically consist of a direct dental abutment (the device that is screwed into the surgically implanted fixture that creates the anchorage for the prosthetic tooth in the mandible or maxilla), a carrier, an impression pick-up, a replica, a healing cap and a burnout cylinder. This is a single-use device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NHA","productCodeName":"Abutment, implant, dental, endosseous"}]},"deviceSizes":{"deviceSize":[]},"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}