[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-QMJ":3},{"classification":4,"mappedDevices":31,"similarCandidates":32,"relatedClassifications":113,"syncDates":114,"translation":121,"marketSummary":128,"recalls":142,"k510s":144,"pmas":157},{"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":26,"updated_at":27,"recall_count":28,"latest_recall_date":29,"k510_count":30,"pma_count":28,"event_count":28},1976,"QMJ","Powered Radiofrequency Toothbrush","2","872.6866","DE","Dental","1","A radiofrequency toothbrush is a device that consists of a handle containing a radiofrequency generator to deliver radiofrequency energy to a brush intended to be applied to the teeth. The device is intended to remove adherent plaque and food debris from the teeth to reduce tooth decay.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":23,"device_class":8,"implant_flag":24,"product_code":6,"review_panel":10,"gmp_exempt_flag":24,"third_party_flag":24,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":23,"life_sustain_support_flag":24,"medical_specialty_description":11,"summary_malfunction_reporting":25},{"k_number":17,"fei_number":20,"registration_number":22},[18,19],"DEN190039","K214078",[21],"3027645761",[21],"","N","Ineligible","2026-08-18T05:52:49.347546+00:00","2026-08-24T02:00:47.318533+00:00",0,null,2,[],[33,42,50,59,67,75,83,91,99,106],{"medical_device_id":34,"generic_name":35,"class_classification":36,"jmdn_code":37,"name_similarity":38,"definition_similarity":39,"vector_similarity":40,"score":41},2608,"電動式歯面清掃用装置","Ⅱ","70707012",0.254902,0.245455,0.792753,0.0325225,{"medical_device_id":43,"generic_name":44,"class_classification":36,"jmdn_code":45,"name_similarity":46,"definition_similarity":47,"vector_similarity":48,"score":49},2603,"歯科用エアスケーラ","70704000",0.177778,0.232824,0.738689,0.028665,{"medical_device_id":51,"generic_name":52,"class_classification":53,"jmdn_code":54,"name_similarity":55,"definition_similarity":56,"vector_similarity":57,"score":58},972,"高周波病変ジェネレータ","Ⅲ","35156000",0.240741,0.26045,0.70809,0.0282187,{"medical_device_id":60,"generic_name":61,"class_classification":36,"jmdn_code":62,"name_similarity":63,"definition_similarity":64,"vector_similarity":65,"score":66},2577,"電動式歯科用ファイル","31878022",0.173913,0.158915,0.727679,0.02578,{"medical_device_id":68,"generic_name":69,"class_classification":53,"jmdn_code":70,"name_similarity":71,"definition_similarity":72,"vector_similarity":73,"score":74},971,"高周波病変プローブ","32531000",0.285714,0.297297,0.663687,0.0163934,{"medical_device_id":76,"generic_name":77,"class_classification":36,"jmdn_code":78,"name_similarity":79,"definition_similarity":80,"vector_similarity":81,"score":82},2583,"歯科用電気回転駆動装置","70690000",0.138462,0.21147,0.769155,0.016129,{"medical_device_id":84,"generic_name":85,"class_classification":36,"jmdn_code":86,"name_similarity":87,"definition_similarity":88,"vector_similarity":89,"score":90},2586,"歯科用電動式ハンドピース","38347000",0.125,0.178832,0.751858,0.015873,{"medical_device_id":92,"generic_name":93,"class_classification":36,"jmdn_code":94,"name_similarity":95,"definition_similarity":96,"vector_similarity":97,"score":98},1336,"MR装置用高周波コイル","40749000",0.245283,0.196429,0.605201,0.015625,{"medical_device_id":100,"generic_name":101,"class_classification":36,"jmdn_code":102,"name_similarity":103,"definition_similarity":104,"vector_similarity":105,"score":98},2579,"歯科用電動式ドリルシステム","44015000",0.150943,0.197183,0.745308,{"medical_device_id":107,"generic_name":108,"class_classification":53,"jmdn_code":109,"name_similarity":95,"definition_similarity":110,"vector_similarity":111,"score":112},937,"ラジオ波焼灼システム","36070000",0.151659,0.622169,0.0153846,[],{"510k":115,"classification":116,"enforcement":117,"event":118,"pma":119,"warning_letter":120},"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":122,"definition_ja":123,"commentary_ja":124,"model_name":125,"source_hash":126,"reviewed_by":29,"reviewed_at":29,"created_at":127,"updated_at":127},"高周波式電動歯ブラシ","高周波歯ブラシは、歯に適用することを意図したブラシに高周波エネルギーを伝えるための高周波発生器を内蔵したハンドルからなる機器である。本機器は、歯垢の付着及び食物残渣を歯から除去し、虫歯を軽減することを目的とする。","米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て市販が認められます。510(k)は、既に合法的に販売されている同等の機器（既存機器）との実質的同等性を示すことにより市販が認められる審査区分であり、PMAのような臨床データに基づく厳格な承認とは異なる位置づけとなります。","claude-sonnet-5","e06033e124c099a5fd86976f46a2a8d3aa929e048950365ab21655628296e649","2026-08-24T03:31:52.244646+00:00",{"product_code":6,"summary_ja":129,"stats":130,"stats_hash":140,"model_name":125,"created_at":141,"updated_at":141},"510(k)の累計件数は2件で、参入企業数は1社、直近5年では1件の判定が確認されており、最新の判定は2023年1月です。不具合報告および回収については、いずれも累計件数が0件であり、確認されていません。",{"pma":131,"k510":132,"as_of":135,"events":136,"recalls":137,"top_problems":139},{"latest":29,"originals":28,"supplements":28},{"total":30,"last5y":133,"latest":134,"applicants":133},1,"2023-01-13","2026-08",{"death":28,"other":28,"total":28,"injury":28,"last5y":28,"malfunction":28,"latest_month":29},{"total":28,"last5y":28,"latest":29,"class_i":28,"class_ii":28,"class_iii":28,"top_root_causes":138},[],[],"95edcb82fe73afe4a6e61a709800527278775914c96fab78cd2a08c7b2560889","2026-08-24T05:19:21.416523+00:00",{"items":143,"total":28},[],{"items":145,"total":30},[146,152],{"k_number":19,"device_name":147,"applicant":148,"decision_date":134,"clearance_type":149,"decision_code":150,"statement_or_summary":151},"Silk’n Toothwave","Home Skinovations , Ltd.","Traditional","SESE","Summary",{"k_number":18,"device_name":153,"applicant":148,"decision_date":154,"clearance_type":155,"decision_code":156,"statement_or_summary":29},"ToothWave™","2020-09-17","Direct","DENG",{"items":158,"total":28},[]]