{"publicDeviceRecordKey":"60b9fe94-68e9-4146-938c-b9315fd1211b","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-01-15T00:00:00.000Z","devicePublishDate":"2015-09-03T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00844868004530","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"CERTAIN® BELLATEK® ENCODE®","versionModelNumber":"IEHA346","catalogNumber":null,"dunsNumber":"119287313","companyName":"ZimVie US Corp LLC","deviceCount":1,"deviceDescription":"CERTAIN® BELLATEK® ENCODE® HEALING ABUTMENT 3.4MM(D) X 3.8MM(P) X 6MM(H)","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"MR Conditional","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)342-5454","phoneExtension":null,"email":"3iPBG-CS@biomet.com"}]},"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":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter 3.4 mm"},{"sizeType":"Height","size":{"unit":"Millimeter","value":"6"},"sizeText":null,"sizeString":"Height: 6 Millimeter"}]},"environmentalConditions":{"storageHandling":[]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null,"premarketSubmissions":{"premarketSubmission":[]}}