[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EFA":3},{"classification":4,"mappedDevices":79,"similarCandidates":80,"relatedClassifications":153,"syncDates":178},{"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":8,"definition":12,"implant_flag":13,"life_sustain_support_flag":13,"gmp_exempt_flag":13,"raw":14,"created_at":72,"updated_at":73,"recall_count":74,"latest_recall_date":75,"k510_count":76,"pma_count":77,"event_count":78},5659,"EFA","Handpiece, Belt And\u002FOr Gear Driven, Dental","1","872.4200","DE","Dental","",false,{"openfda":15,"definition":12,"device_name":7,"review_code":12,"device_class":8,"implant_flag":69,"product_code":6,"review_panel":10,"gmp_exempt_flag":69,"third_party_flag":70,"medical_specialty":10,"regulation_number":9,"submission_type_id":8,"unclassified_reason":12,"life_sustain_support_flag":69,"medical_specialty_description":11,"summary_malfunction_reporting":71},{"k_number":16,"fei_number":42,"registration_number":62},[17,18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"K061701","K960260","K090676","K953865","K090055","K971603","K973062","K070084","K061581","K093894","K101172","K092446","K971606","K092412","K163239","K800163","K002709","K873147","K143465","K040674","K965238","K013185","K960507","K960719","K192809",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"3004884150","3012494290","3003076831","3010281549","3007345485","3012477813","3003637274","4224","2024312","3003755849","3011300255","3007958831","3003719498","1319130","3001779742","3002807636","2916440","1000160293","3015729",[43,44,63,64,46,47,48,49,65,66,51,67,53,54,56,58,59,68,61],"9614977","2032112","1063774","9681479","1722638","8020776","N","Y","Eligible","2026-08-18T05:52:52.949882+00:00","2026-08-18T22:05:38.961415+00:00",3,"2014-07-23",25,0,219,[],[81,89,97,104,111,118,125,132,139,146],{"medical_device_id":82,"generic_name":83,"class_classification":84,"jmdn_code":85,"name_similarity":86,"definition_similarity":77,"vector_similarity":87,"score":88},2989,"歯科用空気駆動式ハンドピース","Ⅱ","40958032",0.377358,0.783671,0.0327869,{"medical_device_id":90,"generic_name":91,"class_classification":92,"jmdn_code":93,"name_similarity":94,"definition_similarity":77,"vector_similarity":95,"score":96},4080,"歯科技工用ドリルリモートドライブハンドピース","Ⅰ","34700000",0.34375,0.774537,0.032002,{"medical_device_id":98,"generic_name":99,"class_classification":84,"jmdn_code":100,"name_similarity":101,"definition_similarity":77,"vector_similarity":102,"score":103},2585,"歯科用ガス圧式ハンドピース","40958000",0.36,0.757851,0.031754,{"medical_device_id":105,"generic_name":106,"class_classification":84,"jmdn_code":107,"name_similarity":108,"definition_similarity":77,"vector_similarity":109,"score":110},2586,"歯科用電動式ハンドピース","38347000",0.283333,0.761721,0.0310245,{"medical_device_id":112,"generic_name":113,"class_classification":84,"jmdn_code":114,"name_similarity":115,"definition_similarity":77,"vector_similarity":116,"score":117},2587,"ストレート・ギアードアングルハンドピース","70692000",0.309091,0.740634,0.0305504,{"medical_device_id":119,"generic_name":120,"class_classification":92,"jmdn_code":121,"name_similarity":122,"definition_similarity":77,"vector_similarity":123,"score":124},4083,"歯科技工用ガス圧式ハンドピース","70745000",0.295082,0.737505,0.0298774,{"medical_device_id":126,"generic_name":127,"class_classification":92,"jmdn_code":128,"name_similarity":129,"definition_similarity":77,"vector_similarity":130,"score":131},4084,"歯科技工用電動式ハンドピース","70746000",0.239437,0.749378,0.0296443,{"medical_device_id":133,"generic_name":134,"class_classification":92,"jmdn_code":135,"name_similarity":136,"definition_similarity":77,"vector_similarity":137,"score":138},4329,"手動式手術用ドリル","36235001",0.223881,0.730273,0.0279734,{"medical_device_id":140,"generic_name":141,"class_classification":84,"jmdn_code":142,"name_similarity":143,"definition_similarity":77,"vector_similarity":144,"score":145},2883,"電池電源式手術用ドリル","37867010",0.230769,0.712098,0.0264808,{"medical_device_id":147,"generic_name":148,"class_classification":92,"jmdn_code":149,"name_similarity":150,"definition_similarity":77,"vector_similarity":151,"score":152},4073,"歯科用ドリルリモートドライブ","37708000",0.22,0.714996,0.0263889,[154,158,162,166,170,174],{"product_code":155,"device_name":156,"device_class":8,"k510_count":157},"EFB","Handpiece, Air-Powered, Dental",261,{"product_code":159,"device_name":160,"device_class":8,"k510_count":161},"EKX","Handpiece, Direct Drive, Ac-Powered",89,{"product_code":163,"device_name":164,"device_class":8,"k510_count":165},"EGS","Handpiece, Contra- And Right-Angle Attachment, Dental",73,{"product_code":167,"device_name":168,"device_class":8,"k510_count":169},"EBW","Controller, Foot, Handpiece And Cord",61,{"product_code":171,"device_name":172,"device_class":8,"k510_count":173},"NYL","Handpiece, Air-Powered, Root Canal Irrigation",5,{"product_code":175,"device_name":176,"device_class":8,"k510_count":177},"EKY","Handpiece, Water-Powered",2,{"510k":179,"classification":180,"enforcement":181,"event":182,"pma":183,"warning_letter":184},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]