[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-OFY":3},{"classification":4,"mappedDevices":55,"similarCandidates":56,"relatedClassifications":137,"syncDates":148},{"id":5,"product_code":6,"device_name":7,"device_class":8,"regulation_number":9,"medical_specialty":10,"medical_specialty_description":11,"review_panel":10,"submission_type_id":12,"definition":13,"implant_flag":14,"life_sustain_support_flag":14,"gmp_exempt_flag":14,"raw":15,"created_at":50,"updated_at":51,"recall_count":52,"latest_recall_date":53,"k510_count":54,"pma_count":54,"event_count":54},3180,"OFY","Dental Implant Surgical Tray","1","872.3980","DE","Dental","7","This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov\u002Fcdrh\u002Fode\u002Fconvkit.Html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":47,"device_class":8,"implant_flag":48,"product_code":6,"review_panel":10,"gmp_exempt_flag":48,"third_party_flag":48,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":47,"life_sustain_support_flag":48,"medical_specialty_description":11,"summary_malfunction_reporting":49},{"fei_number":17,"registration_number":41},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40],"3008346537","3005587147","1221053","3007329020","3004169071","3009888344","3004417597","3013463240","3008534770","3009727738","3004111573","1643817","3004443656","3007518363","3025338240","1000512168","3001236905","3010730876","3011936113","3002902735","3013022399","3004216008","3010948854",[18,19,20,21,23,24,25,26,27,42,28,43,29,30,44,31,45,32,35,46,36,38,40],"8010516","1423537","1061124","8040278","9616088","","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-18T22:05:38.961415+00:00",1,null,0,[],[57,66,75,82,91,99,106,115,122,130],{"medical_device_id":58,"generic_name":59,"class_classification":60,"jmdn_code":61,"name_similarity":62,"definition_similarity":63,"vector_similarity":64,"score":65},4337,"歯科用インプラント手術器具","Ⅰ","70965001",0.511111,0.139319,0.639872,0.0310544,{"medical_device_id":67,"generic_name":68,"class_classification":69,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},2270,"再使用可能な外科処置キット","Ⅱ","37547000",0.176471,0.173184,0.671862,0.0163934,{"medical_device_id":76,"generic_name":77,"class_classification":69,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":74},2899,"電動式歯科用インプラント手術器具","70965002",0.560976,0.131579,0.590359,{"medical_device_id":83,"generic_name":84,"class_classification":85,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},191,"単回使用クラスⅣ処置キット","Ⅳ","33961004",0.166667,0.161994,0.664442,0.016129,{"medical_device_id":92,"generic_name":93,"class_classification":85,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},156,"体内用サージカルテープ","34046000",0.5,0.124224,0.582242,0.015873,{"medical_device_id":100,"generic_name":101,"class_classification":60,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":98},3822,"単回使用クラスⅠ処置キット","33961001",0.169492,0.166154,0.656186,{"medical_device_id":107,"generic_name":108,"class_classification":109,"jmdn_code":110,"name_similarity":111,"definition_similarity":112,"vector_similarity":113,"score":114},1045,"歯科用経歯肉インプラント材","Ⅲ","42354000",0.473684,0.128617,0.557413,0.015625,{"medical_device_id":116,"generic_name":117,"class_classification":69,"jmdn_code":118,"name_similarity":119,"definition_similarity":120,"vector_similarity":121,"score":114},2310,"再使用可能な吸引キット","37447000",0.0425532,0.174419,0.649198,{"medical_device_id":123,"generic_name":124,"class_classification":109,"jmdn_code":125,"name_similarity":126,"definition_similarity":127,"vector_similarity":128,"score":129},1046,"歯科用インプラントシステム","70909000",0.470588,0.144695,0.577499,0.0153846,{"medical_device_id":131,"generic_name":132,"class_classification":109,"jmdn_code":133,"name_similarity":134,"definition_similarity":135,"vector_similarity":136,"score":129},1051,"医薬品含有歯科用接着材料キット","70920003",0.111111,0.13354,0.641475,[138,142,145],{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"NDP","Accessories, Implant, Dental, Endosseous",4,{"product_code":143,"device_name":144,"device_class":8,"k510_count":54},"NYE","Fixture Mount Kit",{"product_code":146,"device_name":147,"device_class":8,"k510_count":54},"QRQ","Non-Irrigation Endosseous Dental Implant Drill Bits",{"510k":149,"classification":150,"enforcement":151,"event":152,"pma":153,"warning_letter":154},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-18T22:42:53.076+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]