[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EHE":3},{"classification":4,"mappedDevices":34,"similarCandidates":35,"relatedClassifications":106,"syncDates":107,"translation":114,"marketSummary":120,"recalls":134,"k510s":136,"pmas":147},{"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":28,"updated_at":29,"recall_count":30,"latest_recall_date":31,"k510_count":32,"pma_count":30,"event_count":33},5423,"EHE","Dispenser, Mercury And\u002FOr Alloy","1","872.3080","DE","Dental","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":26,"product_code":6,"review_panel":10,"gmp_exempt_flag":26,"third_party_flag":26,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":26,"medical_specialty_description":11,"summary_malfunction_reporting":27},{"k_number":17,"fei_number":20,"registration_number":25},[18,19],"K771396","K771749",[21,22,23,24],"1450653","2411797","3009171220","2182762",[21,22,23,24],"N","Eligible","2026-08-18T05:52:52.566809+00:00","2026-08-24T02:00:47.318533+00:00",0,null,2,1,[],[36,44,51,58,65,72,79,86,93,100],{"medical_device_id":37,"generic_name":38,"class_classification":39,"jmdn_code":40,"name_similarity":41,"definition_similarity":30,"vector_similarity":42,"score":43},2685,"歯科用水銀","Ⅱ","35767000",0.25,0.65918,0.0320184,{"medical_device_id":45,"generic_name":46,"class_classification":39,"jmdn_code":47,"name_similarity":48,"definition_similarity":30,"vector_similarity":49,"score":50},2882,"電動式整形外科用セメントディスペンサ","35809002",0.222222,0.651212,0.0312576,{"medical_device_id":52,"generic_name":53,"class_classification":54,"jmdn_code":55,"name_similarity":41,"definition_similarity":30,"vector_similarity":56,"score":57},4307,"手動式整形外科用セメントディスペンサ","Ⅰ","35809001",0.62641,0.0306218,{"medical_device_id":59,"generic_name":60,"class_classification":54,"jmdn_code":61,"name_similarity":62,"definition_similarity":30,"vector_similarity":63,"score":64},3321,"水銀毛細管体温計","35397000",0.18,0.627176,0.0298574,{"medical_device_id":66,"generic_name":67,"class_classification":39,"jmdn_code":68,"name_similarity":69,"definition_similarity":30,"vector_similarity":70,"score":71},2684,"歯科アマルガム用合金","34836000",0.145833,0.704246,0.0297268,{"medical_device_id":73,"generic_name":74,"class_classification":39,"jmdn_code":75,"name_similarity":76,"definition_similarity":30,"vector_similarity":77,"score":78},1908,"水銀バルーン用シングルルーメンチューブ","32058000",0.185185,0.613315,0.0283716,{"medical_device_id":80,"generic_name":81,"class_classification":39,"jmdn_code":82,"name_similarity":83,"definition_similarity":30,"vector_similarity":84,"score":85},2659,"歯科非鋳造用金合金","70771000",0.142857,0.617274,0.0265005,{"medical_device_id":87,"generic_name":88,"class_classification":54,"jmdn_code":89,"name_similarity":90,"definition_similarity":30,"vector_similarity":91,"score":92},4109,"歯科用易溶合金","70800000",0.159091,0.605508,0.0263339,{"medical_device_id":94,"generic_name":95,"class_classification":39,"jmdn_code":96,"name_similarity":97,"definition_similarity":30,"vector_similarity":98,"score":99},2670,"歯科用銀パラジウム合金ろう","70782000",0.137931,0.625631,0.0261905,{"medical_device_id":101,"generic_name":102,"class_classification":39,"jmdn_code":103,"name_similarity":97,"definition_similarity":30,"vector_similarity":104,"score":105},2675,"歯科用ニッケル・クロム系合金ろう","70787000",0.60787,0.0242647,[],{"510k":108,"classification":109,"enforcement":110,"event":111,"pma":112,"warning_letter":113},"2026-08-24T02:00:50.297+00:00","2026-08-24T02:00:49.319+00:00","2026-08-24T02:00:50.059+00:00","2026-08-24T04:00:49.186+00:00","2026-08-24T02:00:50.609+00:00","2026-08-20T03:28:02.95+00:00",{"product_code":6,"device_name_ja":115,"definition_ja":31,"commentary_ja":116,"model_name":117,"source_hash":118,"reviewed_by":31,"reviewed_at":31,"created_at":119,"updated_at":119},"水銀・合金ディスペンサー","本品は歯科治療において歯科用アマルガムの調製に用いる水銀及び／又は合金を計量・分配するための器具です。米国ではクラスIに分類されており、市販前届出（510(k)）が免除される区分とされています。これは、リスクが低く、一般的な管理のみで安全性・有効性を確保できると判断された機器であることを意味します。","claude-sonnet-5","e60c0ece70d4090cdb68a8fe12432dbaa9a521801c03ffc2712d3c30cfc9fe11","2026-08-24T01:48:55.976021+00:00",{"product_code":6,"summary_ja":121,"stats":122,"stats_hash":132,"model_name":117,"created_at":133,"updated_at":133},"本製品は届出免除の対象で、510(k)の累計件数は2件、参入企業数は2社となっており、直近5年の届出はありません。不具合報告は累計1件で、死亡・傷害の報告はなく、不具合（Malfunction）に関する報告が1件確認されています。回収については累計0件で、クラスI〜IIIのいずれについても報告は確認されていません。",{"pma":123,"k510":124,"as_of":126,"events":127,"recalls":129,"top_problems":131},{"latest":31,"originals":30,"supplements":30},{"total":32,"last5y":30,"latest":125,"applicants":32},"1977-09-28","2026-08",{"death":30,"other":30,"total":33,"injury":30,"last5y":30,"malfunction":33,"latest_month":128},"1999-08",{"total":30,"last5y":30,"latest":31,"class_i":30,"class_ii":30,"class_iii":30,"top_root_causes":130},[],[],"93f6ed1be8d1d8250e90cbd47092d2710aed2175908342161da112609207dfe3","2026-08-24T04:17:09.731512+00:00",{"items":135,"total":30},[],{"items":137,"total":32},[138,143],{"k_number":19,"device_name":139,"applicant":140,"decision_date":125,"clearance_type":141,"decision_code":142,"statement_or_summary":31},"AMALGAM DISPENSER","New Dimensions IN Medicine, Inc.","Traditional","SESE",{"k_number":18,"device_name":144,"applicant":145,"decision_date":146,"clearance_type":141,"decision_code":142,"statement_or_summary":31},"DISPENSER, MERCURY & TABLET\u002FPOWDER","Johnson & Johnson Professionals, Inc.","1977-08-03",{"items":148,"total":30},[]]