[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NEI":3},{"classification":4,"mappedDevices":56,"similarCandidates":57,"relatedClassifications":128,"syncDates":129,"translation":53,"marketSummary":53,"recalls":136,"k510s":138,"pmas":169},{"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":15,"gmp_exempt_flag":15,"raw":16,"created_at":50,"updated_at":51,"recall_count":52,"latest_recall_date":53,"k510_count":54,"pma_count":52,"event_count":55},3553,"NEI","Prosthesis, Condyle, Mandibular, Temporary","2","872.4770","DE","Dental","1","",true,false,{"openfda":17,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":47,"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":13,"life_sustain_support_flag":48,"medical_specialty_description":11,"summary_malfunction_reporting":49},{"k_number":18,"fei_number":26,"registration_number":42},[19,20,21,22,23,24,25],"K031701","K002790","K133285","K081747","K990667","K990637","K063181",[27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"3015440604","3002807464","1825034","3008868758","3034676720","1032347","2027754","3015869493","3002821504","1000525271","3000270450","1000221916","3008812560","3015399803","3009417901",[43,27,44,29,45,30,31,32,33,37,46,34,39,40,41],"9610905","1057425","8010177","1057946","Y","N","Eligible","2026-08-18T05:52:51.341121+00:00","2026-08-18T22:05:38.961415+00:00",0,null,7,24,[],[58,66,73,80,87,94,101,108,115,121],{"medical_device_id":59,"generic_name":60,"class_classification":61,"jmdn_code":62,"name_similarity":63,"definition_similarity":52,"vector_similarity":64,"score":65},599,"人工顎関節","Ⅲ","35943000",0.530612,0.78345,0.0325225,{"medical_device_id":67,"generic_name":68,"class_classification":61,"jmdn_code":69,"name_similarity":70,"definition_similarity":52,"vector_similarity":71,"score":72},635,"人工側頭下顎関節円板","36260000",0.541667,0.739526,0.0322665,{"medical_device_id":74,"generic_name":75,"class_classification":61,"jmdn_code":76,"name_similarity":77,"definition_similarity":52,"vector_similarity":78,"score":79},634,"全人工側頭下顎関節","36042000",0.481481,0.76874,0.032002,{"medical_device_id":81,"generic_name":82,"class_classification":61,"jmdn_code":83,"name_similarity":84,"definition_similarity":52,"vector_similarity":85,"score":86},570,"片側型人工膝関節","32833000",0.333333,0.703623,0.0292111,{"medical_device_id":88,"generic_name":89,"class_classification":61,"jmdn_code":90,"name_similarity":91,"definition_similarity":52,"vector_similarity":92,"score":93},624,"人工下顎骨","35261000",0.272727,0.724616,0.0274254,{"medical_device_id":95,"generic_name":96,"class_classification":61,"jmdn_code":97,"name_similarity":98,"definition_similarity":52,"vector_similarity":99,"score":100},670,"耳用補綴材","35262000",0.27907,0.681929,0.0258161,{"medical_device_id":102,"generic_name":103,"class_classification":61,"jmdn_code":104,"name_similarity":105,"definition_similarity":52,"vector_similarity":106,"score":107},628,"人工全耳小骨","35674000",0.288462,0.668575,0.0249346,{"medical_device_id":109,"generic_name":110,"class_classification":61,"jmdn_code":111,"name_similarity":112,"definition_similarity":52,"vector_similarity":113,"score":114},547,"ヘパリン使用一時留置型人工血管","70487103",0.351351,0.595074,0.015625,{"medical_device_id":116,"generic_name":117,"class_classification":61,"jmdn_code":118,"name_similarity":119,"definition_similarity":52,"vector_similarity":120,"score":114},617,"人工上顎骨","33168000",0.25,0.733418,{"medical_device_id":122,"generic_name":123,"class_classification":61,"jmdn_code":124,"name_similarity":125,"definition_similarity":52,"vector_similarity":126,"score":127},660,"人工耳・鼻・喉用補綴材","33310103",0.233333,0.732703,0.0153846,[],{"510k":130,"classification":131,"enforcement":132,"event":133,"pma":134,"warning_letter":135},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-20T03:28:02.95+00:00",{"items":137,"total":52},[],{"items":139,"total":54},[140,147,151,154,158,162,166],{"k_number":21,"device_name":141,"applicant":142,"decision_date":143,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"STRYKER TEMPORARY CONDYLAR PROSTHESIS","Stryker","2014-04-09","Traditional","SESE","Summary",{"k_number":22,"device_name":148,"applicant":149,"decision_date":150,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"MODIFICATION TO SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM","Synthes (Usa)","2008-09-05",{"k_number":25,"device_name":152,"applicant":149,"decision_date":153,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"SYNTHES (USA) CONDYLAR HEAD ADD-ON SYSTEM","2007-01-05",{"k_number":19,"device_name":155,"applicant":156,"decision_date":157,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"OSTEOMED TEMPORARY CONDYLAR ATTACHMENT SYSTEM","Osteomed LP","2004-07-08",{"k_number":20,"device_name":159,"applicant":160,"decision_date":161,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"ADD-ON CONDYLE","Walter Lorenz Surgical, Inc.","2001-08-06",{"k_number":23,"device_name":163,"applicant":164,"decision_date":165,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"KLS-MARTIN TEMPORARY CONDYLAR IMPLANT","KLS-Martin L.P.","2001-07-27",{"k_number":24,"device_name":167,"applicant":149,"decision_date":168,"clearance_type":144,"decision_code":145,"statement_or_summary":146},"SYNTHES LOCKING RECONSTRUCTION PLATE (LRP) WITH CONDYLAR HEAD","1999-10-22",{"items":170,"total":52},[]]