[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NBL":3},{"classification":4,"mappedDevices":74,"similarCandidates":75,"relatedClassifications":148,"syncDates":153,"translation":160,"marketSummary":166,"recalls":181,"k510s":183,"pmas":265},{"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":68,"updated_at":69,"recall_count":70,"latest_recall_date":71,"k510_count":72,"pma_count":70,"event_count":73},4080,"NBL","Light-Induced Fluorescence Caries Detector ","2","872.1745","DE","Dental","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":66,"product_code":6,"review_panel":10,"gmp_exempt_flag":66,"third_party_flag":66,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":66,"medical_specialty_description":11,"summary_malfunction_reporting":67},{"k_number":17,"fei_number":42,"registration_number":62},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41],"DEN990002","K121685","K092583","K090598","K040063","K170822","K171007","K112139","K221249","K051909","K042394","K221275","K090169","K043156","K252464","K231722","K063321","K150672","K242103","K093705","K223470","K183471","K111423","K111321",[43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61],"3006621353","3004884150","3015172511","3031568217","3015509619","3003637274","3009560013","3004084693","3010728558","3014980444","3031697712","3015193486","3003719498","1000523896","3032734659","3001052305","3029904428","3015729","3011533696",[43,44,63,45,46,47,48,49,51,52,53,54,57,64,65,58,59,60,61],"9614977","9615782","3029780","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-24T02:00:47.656965+00:00",0,null,24,6,[],[76,84,90,97,105,112,119,126,133,141],{"medical_device_id":77,"generic_name":78,"class_classification":79,"jmdn_code":80,"name_similarity":81,"definition_similarity":70,"vector_similarity":82,"score":83},2597,"光学式う蝕検出装置","Ⅱ","33995020",0.313726,0.818652,0.0327869,{"medical_device_id":85,"generic_name":86,"class_classification":79,"jmdn_code":87,"name_similarity":81,"definition_similarity":70,"vector_similarity":88,"score":89},2598,"電気式う蝕検出装置","33995030",0.756804,0.0322581,{"medical_device_id":91,"generic_name":92,"class_classification":79,"jmdn_code":93,"name_similarity":94,"definition_similarity":70,"vector_similarity":95,"score":96},2596,"光学的歯石歯垢検出器","33995010",0.171875,0.734065,0.0303658,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":70,"vector_similarity":103,"score":104},3510,"免疫蛍光分析装置","Ⅰ","35707010",0.147541,0.683978,0.0275298,{"medical_device_id":106,"generic_name":107,"class_classification":100,"jmdn_code":108,"name_similarity":109,"definition_similarity":70,"vector_similarity":110,"score":111},4061,"歯科用口腔内手術灯","12352000",0.15873,0.646239,0.0272222,{"medical_device_id":113,"generic_name":114,"class_classification":100,"jmdn_code":115,"name_similarity":116,"definition_similarity":70,"vector_similarity":117,"score":118},3263,"X線平面検出器","70029000",0.189655,0.630229,0.0271493,{"medical_device_id":120,"generic_name":121,"class_classification":100,"jmdn_code":122,"name_similarity":123,"definition_similarity":70,"vector_similarity":124,"score":125},3283,"X線装置用蛍光板","37684000",0.172414,0.631123,0.0266106,{"medical_device_id":127,"generic_name":128,"class_classification":79,"jmdn_code":129,"name_similarity":130,"definition_similarity":70,"vector_similarity":131,"score":132},3190,"ICG蛍光観察装置","71076002",0.225806,0.617248,0.015873,{"medical_device_id":134,"generic_name":135,"class_classification":136,"jmdn_code":137,"name_similarity":138,"definition_similarity":70,"vector_similarity":139,"score":140},697,"透析装置用透析液量検知器","Ⅲ","32126000",0.191176,0.560045,0.015625,{"medical_device_id":142,"generic_name":143,"class_classification":100,"jmdn_code":144,"name_similarity":145,"definition_similarity":70,"vector_similarity":146,"score":147},3511,"移動式免疫蛍光分析装置","35707020",0.132353,0.680128,0.0153846,[149],{"product_code":150,"device_name":151,"device_class":8,"k510_count":152},"NTK","Light Transmission Caries Detector",12,{"510k":154,"classification":155,"enforcement":156,"event":157,"pma":158,"warning_letter":159},"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":161,"definition_ja":71,"commentary_ja":162,"model_name":163,"source_hash":164,"reviewed_by":71,"reviewed_at":71,"created_at":165,"updated_at":165},"光誘導蛍光式う蝕検出装置","本機器は米国FDAの規制上クラス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場に出すことが可能な医療機器です。クラスIIは中程度のリスクを有する機器区分であり、一般管理に加えて特別管理（性能規格の遵守等）が求められますが、クラスIIIのような市販前承認（PMA）ほど厳格な審査は課されません。","claude-sonnet-5","595d86aa11334049fd3331b94aa006d0e80523097afe2fdfa1e6ce3dccdd45e7","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":167,"stats":168,"stats_hash":179,"model_name":163,"created_at":180,"updated_at":180},"510(k)の累計届出件数は約20件で、18社が参入しており、直近5年間でも約6件の届出が行われています。不具合報告は累計約6件で、すべてMalfunction(不具合)であり、死亡・傷害の報告は確認されていません。回収については累計件数が0件であり、該当する事例は確認されていません。",{"pma":169,"k510":170,"as_of":173,"events":174,"recalls":176,"top_problems":178},{"latest":71,"originals":70,"supplements":70},{"total":72,"last5y":73,"latest":171,"applicants":172},"2026-04-28",18,"2026-08",{"death":70,"other":70,"total":73,"injury":70,"last5y":70,"malfunction":73,"latest_month":175},"2020-02",{"total":70,"last5y":70,"latest":71,"class_i":70,"class_ii":70,"class_iii":70,"top_root_causes":177},[],[],"9cd846522508e8cd098d4df0c70fa69cc0b4c6588f407ef73e2dd264ad7c3a59","2026-08-24T04:57:04.90455+00:00",{"items":182,"total":70},[],{"items":184,"total":72},[185,191,195,199,203,207,210,214,218,222,226,229,233,237,243,247,250,253,257,261],{"k_number":32,"device_name":186,"applicant":187,"decision_date":171,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"Surgical Microscope (OMS2360, OMS2380)","Zumax Medical Co., Ltd.","Traditional","SESE","Summary",{"k_number":36,"device_name":192,"applicant":193,"decision_date":194,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"TRIOS Ready Tip","3Shape TRIOS A\u002FS","2025-04-04",{"k_number":29,"device_name":196,"applicant":197,"decision_date":198,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"Qraycam PRO","AIOBIO Co., Ltd.","2024-09-04",{"k_number":33,"device_name":200,"applicant":201,"decision_date":202,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"SmarTooth","Smartooth Co., Ltd.","2024-05-01",{"k_number":38,"device_name":204,"applicant":205,"decision_date":206,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"C50","Sopro","2023-12-14",{"k_number":26,"device_name":208,"applicant":193,"decision_date":209,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"L1P-1F (TRIOS 5)","2022-09-16",{"k_number":39,"device_name":211,"applicant":212,"decision_date":213,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"IC-WHCD100 (Inspire)","Good Doctors Co., Ltd.","2020-07-02",{"k_number":24,"device_name":215,"applicant":216,"decision_date":217,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"Fluorescence Mode","Carl Zeiss Suzhou Co., Ltd.","2018-05-03",{"k_number":23,"device_name":219,"applicant":220,"decision_date":221,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"Electronic Caries Detector","Ortek Therapeutics, Inc.","2017-09-11",{"k_number":35,"device_name":223,"applicant":224,"decision_date":225,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"VistaCam iX Proof","Durr Dental AG","2016-01-27",{"k_number":19,"device_name":227,"applicant":205,"decision_date":228,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"SOPROCARE","2013-03-12",{"k_number":25,"device_name":230,"applicant":231,"decision_date":232,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"THE CANARY SYSTEM","Quantum Dental Technologies, Inc.","2012-10-26",{"k_number":40,"device_name":234,"applicant":235,"decision_date":236,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"CS 1600 INTRAORAL CAMERA","Carestream Health, Inc.","2012-03-02",{"k_number":41,"device_name":238,"applicant":239,"decision_date":240,"clearance_type":241,"decision_code":189,"statement_or_summary":242},"REMOTE VIEW SOFTWARE","Cariescan , Ltd.","2011-05-17","Special","Statement",{"k_number":37,"device_name":244,"applicant":245,"decision_date":246,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"FUORECAM","Therapeutic Technologies, Inc.","2010-04-23",{"k_number":20,"device_name":248,"applicant":205,"decision_date":249,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"SOPROLIFE","2010-01-13",{"k_number":21,"device_name":251,"applicant":239,"decision_date":252,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"CARIESCAN PRO","2009-12-15",{"k_number":30,"device_name":254,"applicant":255,"decision_date":256,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"SPECTRA FLUORESCENCE CARIES DETECTION DEVICE","Air Techniques, Inc.","2009-08-18",{"k_number":34,"device_name":258,"applicant":259,"decision_date":260,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"D-CARIE\u002FDETECTAR, MODELS N121, N123, N133, N134, N135 & N138","Neks Technologies, Inc.","2007-03-30",{"k_number":27,"device_name":262,"applicant":263,"decision_date":264,"clearance_type":188,"decision_code":189,"statement_or_summary":190},"DIAGNODENT","Kavo America","2005-10-21",{"items":266,"total":70},[]]