{"publicDeviceRecordKey":"ad4d4173-1cac-4a1b-8f9d-cbb90f844f65","publicVersionStatus":"New","deviceRecordStatus":"Published","publicVersionNumber":1,"publicVersionDate":"2023-06-27T00:00:00.000Z","devicePublishDate":"2023-06-19T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"D768GA210010","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"Genesis ACTIVE","versionModelNumber":"GA21001","catalogNumber":null,"dunsNumber":"787471015","companyName":"KEYSTONE DENTAL, INC.","deviceCount":1,"deviceDescription":"Genesis Active Conical Implant, Ø3.5x10.0mm","DMExempt":true,"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(866)902-9272","phoneExtension":null,"email":"customersupport@keystonedental.com"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K223814","supplementNumber":"000"}]},"gmdnTerms":{"gmdn":[{"gmdnCode":"55849","gmdnPTName":"Screw endosteal dental implant, two-piece","gmdnPTDefinition":"A sterile device made of alloplastic materials [e.g., titanium (Ti), stainless steel, ceramic] intended to be surgically implanted into alveolar and/or basal bone of the mandible or maxilla to provide support and a means of retention for a dental prosthesis (e.g., bridge, single-tooth, overdenture). It is a two-piece device composed of an anchorage component (implant body) in the form of a threaded screw that is implanted into bone, and a retention component (implant abutment), typically attached to the anchorage component after implantation, that protrudes through gingival tissues to support the prosthesis.","implantable":true,"gmdnCodeStatus":"Active"}]},"productCodes":{"fdaProductCode":[{"productCode":"DZE","productCodeName":"IMPLANT, ENDOSSEOUS, ROOT-FORM"}]},"deviceSizes":{"deviceSize":[{"sizeType":"Length","size":{"unit":"Millimeter","value":"10"},"sizeText":null,"sizeString":"Length: 10 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"3.5"},"sizeText":null,"sizeString":"Outer Diameter: 3.5 Millimeter"}]},"environmentalConditions":{"storageHandling":[{"storageHandlingType":"Special Storage Condition, Specify","storageHandlingHigh":{"unit":"","value":""},"storageHandlingLow":{"unit":"","value":""},"storageHandlingSpecialConditionText":"Keep out of sunlight"}]},"sterilization":{"deviceSterile":true,"sterilizationPriorToUse":false,"methodTypes":{"sterilizationMethod":[]}},"xmlns":"http://www.fda.gov/cdrh/gudid","xsi":"http://www.w3.org/2001/XMLSchema-instance","anomaly":null}