{"publicDeviceRecordKey":"830daf59-84b3-44b1-b389-12f69941f7e4","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":6,"publicVersionDate":"2026-01-15T00:00:00.000Z","devicePublishDate":"2016-03-24T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"00844868024774","deviceIdType":"Primary","deviceIdIssuingAgency":"GS1","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"NAVIGATOR®","versionModelNumber":"SGTD585L","catalogNumber":null,"dunsNumber":"119287313","companyName":"ZimVie US Corp LLC","deviceCount":1,"deviceDescription":"TAPERED NAVIGATOR® SHAPING DRILL 5MM(D) X 8.5MM(L) LONG","DMExempt":false,"premarketExempt":true,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":false,"lotBatch":true,"serialNumber":false,"manufacturingDate":false,"expirationDate":false,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+1(800)342-5454","phoneExtension":null,"email":"3iPBG-CS@biomet.com"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"45714","gmdnPTName":"Fixture/appliance dental drill bit, reusable","gmdnPTDefinition":"A shaft of metal intended to be used in dental surgery to create channels of appropriate depth and diameter in bone (osteotomy) of the oral cavity to facilitate the implantation of a dental fixture/appliance. The device is typically available in a set of graduated sizes and various forms and functions (e.g., guide, pilot, twist, cortical, conical). It is attached to a manual or power tool handpiece that provides rotation. This is a reusable device.","implantable":false,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"NDP","productCodeName":"ACCESSORIES, IMPLANT, DENTAL, ENDOSSEOUS"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Device Size Text, specify","size":{"unit":"","value":""},"sizeText":"Diameter 5 mm"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"8.5"},"sizeText":null,"sizeString":"Length: 8.5 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,"premarketSubmissions":{"premarketSubmission":[]}}