{"publicDeviceRecordKey":"777616eb-cf22-4b35-93e8-043eba7e99c3","publicVersionStatus":"Update","deviceRecordStatus":"Published","publicVersionNumber":3,"publicVersionDate":"2018-07-06T00:00:00.000Z","devicePublishDate":"2016-09-12T00:00:00.000Z","deviceCommDistributionEndDate":null,"deviceCommDistributionStatus":"In Commercial Distribution","identifiers":{"identifier":[{"deviceId":"EAGN60008K3PROS9","deviceIdType":"Primary","deviceIdIssuingAgency":"HIBCC","containsDINumber":null,"pkgQuantity":null,"pkgDiscontinueDate":null,"pkgStatus":null,"pkgType":null}]},"brandName":"K3Pro Konus Dental Implants","versionModelNumber":"60008K3Pro.S","catalogNumber":"60008K3Pro.S","dunsNumber":"312649568","companyName":"Argon Medical Productions \u0026 Vertriebs Gesellschaft mbH \u0026 Co. KG","deviceCount":1,"deviceDescription":"6.0 x 8.0mm K3Pro \"Sure\" Implant with 3mm Well\n","DMExempt":false,"premarketExempt":false,"deviceHCTP":false,"deviceKit":false,"deviceCombinationProduct":false,"singleUse":true,"lotBatch":false,"serialNumber":true,"manufacturingDate":false,"expirationDate":true,"donationIdNumber":false,"labeledContainsNRL":false,"labeledNoNRL":false,"MRISafetyStatus":"Labeling does not contain MRI Safety Information","rx":true,"otc":false,"contacts":{"customerContact":[{"phone":"+17158981434","phoneExtension":null,"email":"purchasing@argondentalusa.com"},{"phone":"+49672130960","phoneExtension":null,"email":"info@argon-dental.de"}]},"premarketSubmissions":{"premarketSubmission":[{"submissionNumber":"K141159","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":"Lumen/Inner Diameter","size":{"unit":"Millimeter","value":"3"},"sizeText":null,"sizeString":"Lumen/Inner Diameter: 3 Millimeter"},{"sizeType":"Length","size":{"unit":"Millimeter","value":"8"},"sizeText":null,"sizeString":"Length: 8 Millimeter"},{"sizeType":"Outer Diameter","size":{"unit":"Millimeter","value":"6"},"sizeText":null,"sizeString":"Outer Diameter: 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}