[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EEG":3},{"classification":4,"mappedDevices":167,"similarCandidates":168,"relatedClassifications":240,"syncDates":241,"translation":248,"marketSummary":254,"recalls":275,"k510s":277,"pmas":328},{"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":161,"updated_at":162,"recall_count":163,"latest_recall_date":164,"k510_count":165,"pma_count":163,"event_count":166},3106,"EEG","Heat Source For Bleaching Teeth","1","872.6475","DE","Dental","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":159,"product_code":6,"review_panel":10,"gmp_exempt_flag":159,"third_party_flag":159,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":159,"medical_specialty_description":11,"summary_malfunction_reporting":160},{"k_number":17,"fei_number":30,"registration_number":144},[18,19,20,21,22,23,24,25,26,27,28,29],"K790378","K832179","K862385","K041392","K063704","K110888","K854692","K052040","K895174","K122725","K042153","K884937",[31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143],"3021282523","3013600135","3012803257","3015619973","3014610038","3011800195","3016076077","3002808025","3010585908","3000719964","3012242594","3006552587","3004105228","3032193293","3004069780","3012896103","1000126901","3003258642","3038718579","3013662621","3015050498","3011210633","3002948158","1825660","3030670291","3004046477","3008763803","3009937681","3006948529","3011170521","3007060769","3036269993","3019381139","3021636076","3021031939","3035708505","3043126851","3017265430","3017618900","3006982887","3012041047","3008475975","3015287618","1051594","3017268636","3017248108","3014683120","2024949","3004082121","3004102507","3029507159","3013520830","3016661538","3014953747","3004475754","3010610239","2221095","3023895623","3036675345","3004505220","2518467","3003169405","3008882689","3014268398","3004112621","3034048670","3021963363","3013612053","3011430871","3021593806","3016660845","3011964664","3002718942","3014545089","3012421607","3024555465","3009834955","3014737458","3008898734","3008910197","3013524663","3008590661","3025428426","3003922211","3015338588","3043648115","3042586390","3008648418","3014314529","1316092","3002772487","3009171220","3010683450","3003694926","3014468707","1450819","3011279497","3000719926","1000479488","3010486573","1000582314","3012104022","3005607635","3010493153","3035375032","3011644607","3030795695","3013521677","3030192581","3012133441","3017181358","1000493876","3005791808",[31,32,33,34,35,36,37,39,41,42,145,43,44,45,146,147,46,49,50,148,51,52,54,55,56,57,58,59,149,60,61,62,63,64,65,66,67,68,150,69,70,71,72,73,74,75,76,151,77,78,79,80,81,82,83,84,85,152,86,88,89,90,91,92,93,94,153,95,96,97,98,99,100,101,102,104,105,106,107,108,110,111,112,113,114,115,154,116,117,118,119,120,122,123,124,125,155,156,157,126,127,130,132,133,134,135,136,137,138,139,140,158,141,143],"9614573","9680012","3026630","8044167","9613230","9680864","1530449","2086043","8010908","2031532","8043962","1725006","2218158","3008925277","N","Eligible","2026-08-18T05:52:50.955415+00:00","2026-08-24T02:00:48.225237+00:00",0,null,12,85,[],[169,177,185,192,200,207,214,220,227,233],{"medical_device_id":170,"generic_name":171,"class_classification":172,"jmdn_code":173,"name_similarity":174,"definition_similarity":163,"vector_similarity":175,"score":176},4049,"歯面漂白用加熱装置","Ⅰ","31806009",0.372093,0.83333,0.0327869,{"medical_device_id":178,"generic_name":179,"class_classification":180,"jmdn_code":181,"name_similarity":182,"definition_similarity":163,"vector_similarity":183,"score":184},1049,"歯科用漂白材","Ⅲ","38785000",0.227273,0.722163,0.032002,{"medical_device_id":186,"generic_name":187,"class_classification":172,"jmdn_code":188,"name_similarity":189,"definition_similarity":163,"vector_similarity":190,"score":191},4090,"歯科技工用ヒータプレス","70749000",0.172414,0.682255,0.0279124,{"medical_device_id":193,"generic_name":194,"class_classification":195,"jmdn_code":196,"name_similarity":197,"definition_similarity":163,"vector_similarity":198,"score":199},2616,"歯面漂白用活性化装置","Ⅱ","70717000",0.140351,0.731619,0.016129,{"medical_device_id":201,"generic_name":202,"class_classification":195,"jmdn_code":203,"name_similarity":204,"definition_similarity":163,"vector_similarity":205,"score":206},3037,"熱流補償式体温計用プログラム","70043012",0.203125,0.523765,0.015873,{"medical_device_id":208,"generic_name":209,"class_classification":195,"jmdn_code":210,"name_similarity":211,"definition_similarity":163,"vector_similarity":212,"score":213},2375,"人工心肺用熱交換器","11973112",0.2,0.59632,0.015625,{"medical_device_id":215,"generic_name":216,"class_classification":172,"jmdn_code":217,"name_similarity":218,"definition_similarity":163,"vector_similarity":219,"score":213},4107,"歯科技工用セラミックス加熱加圧成形器","70759000",0.1375,0.68562,{"medical_device_id":221,"generic_name":222,"class_classification":195,"jmdn_code":223,"name_similarity":224,"definition_similarity":163,"vector_similarity":225,"score":226},2398,"血液回路用モニタリングセット","70559000",0.192308,0.45872,0.0153846,{"medical_device_id":228,"generic_name":229,"class_classification":172,"jmdn_code":230,"name_similarity":231,"definition_similarity":163,"vector_similarity":232,"score":226},4098,"歯科技工用ポーセレン焼成炉","35762000",0.0923077,0.684006,{"medical_device_id":234,"generic_name":235,"class_classification":172,"jmdn_code":236,"name_similarity":237,"definition_similarity":163,"vector_similarity":238,"score":239},3909,"温水低温殺菌装置","44555000",0.0322581,0.682518,0.0151515,[],{"510k":242,"classification":243,"enforcement":244,"event":245,"pma":246,"warning_letter":247},"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":249,"definition_ja":164,"commentary_ja":250,"model_name":251,"source_hash":252,"reviewed_by":164,"reviewed_at":164,"created_at":253,"updated_at":253},"歯牙漂白用熱源装置","本機器は、歯牙の漂白処置に用いる薬剤の反応を促進するために熱を供給する装置です。米国ではクラスIに分類されており、市販前届出（510(k)）の対象からも除外される、規制上のリスクが低い機器として扱われています。","claude-sonnet-5","03c10d284fff28fe03553519768b168ccb004245b5f7b9ca841df0659e2b97eb","2026-08-24T01:48:55.976021+00:00",{"product_code":6,"summary_ja":255,"stats":256,"stats_hash":273,"model_name":251,"created_at":274,"updated_at":274},"このプロダクトコードでは、510(k)による届出が累計12件、申請企業数は12社となっており、直近5年間の届出は確認されていません。不具合報告（MDR）は累計で約90件あり、死亡の報告はなく、傷害が53件と過半数を占め、不具合（Malfunction）は5件です。主な問題としては、Patient Device Interaction Problem（患者と機器の相互作用に関する問題）、Unintended Electrical Shock（意図しない電気的ショック）、Improper or Incorrect Procedure or Method（不適切または誤った手順・方法）が挙げられています。回収については、累計件数は確認されていません。",{"pma":257,"k510":258,"as_of":260,"events":261,"recalls":267,"top_problems":269},{"latest":164,"originals":163,"supplements":163},{"total":165,"last5y":163,"latest":259,"applicants":165},"2012-11-27","2026-08",{"death":163,"other":262,"total":166,"injury":263,"last5y":264,"malfunction":265,"latest_month":266},27,53,15,5,"2025-08",{"total":163,"last5y":163,"latest":164,"class_i":163,"class_ii":163,"class_iii":163,"top_root_causes":268},[],[270,271,272],"Patient Device Interaction Problem","Unintended Electrical Shock","Improper or Incorrect Procedure or Method","191eaa59371f80b50eafaa954a7931c751809d6fdfe852ab7edc7324036a09b1","2026-08-24T04:17:09.731512+00:00",{"items":276,"total":163},[],{"items":278,"total":165},[279,285,289,293,297,301,304,308,312,316,320,324],{"k_number":27,"device_name":280,"applicant":281,"decision_date":259,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"TANDA PEARL, ULTRAWYTE, PEARL","Syneron Beauty","Traditional","SESE","Summary",{"k_number":23,"device_name":286,"applicant":287,"decision_date":288,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"ABSOLUTE WHITE LIGHT","Dr. Fresh, Inc.","2012-01-12",{"k_number":22,"device_name":290,"applicant":291,"decision_date":292,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"BRITEWHITE TEETH WHITENING SYSTEM, MODEL BW1101","Beks Incorporated","2007-02-20",{"k_number":25,"device_name":294,"applicant":295,"decision_date":296,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"QUICKSMILE","Cosmetic Dental Materials, Inc.","2005-10-18",{"k_number":28,"device_name":298,"applicant":299,"decision_date":300,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"SOUTH BEACH SMILE LIGHT WHITENING SYSTEM","Dentovations, Inc.","2004-11-08",{"k_number":21,"device_name":302,"applicant":303,"decision_date":300,"clearance_type":282,"decision_code":283,"statement_or_summary":284},"SONX 35 ULTRASONIC BLEACHING SYSTEM; SONIWHITE ULTRA SONIC, MODEL QUICK WHITE US","CAO Group, Inc.",{"k_number":26,"device_name":305,"applicant":306,"decision_date":307,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"UNION BROACH BLEACHING LIGHT","Union Broach, Div. Moyco Industries, Inc.","1990-04-13",{"k_number":29,"device_name":309,"applicant":310,"decision_date":311,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"BEEHIVE-64 OR BEEHIVE-32, DIGITAL EEG RECORDING","Grass-Telefactor Product Group","1989-04-14",{"k_number":20,"device_name":313,"applicant":314,"decision_date":315,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"SCHEIN BLEACHING UNIT","Henry Schein, Inc.","1986-10-30",{"k_number":24,"device_name":317,"applicant":318,"decision_date":319,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"MONARCH II BLEACHING INSTRUMENT","Almore Intl., Inc.","1986-05-12",{"k_number":19,"device_name":321,"applicant":322,"decision_date":323,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"HOT PROBE MODEL 6001","Analytic Technology","1983-10-04",{"k_number":18,"device_name":325,"applicant":326,"decision_date":327,"clearance_type":282,"decision_code":283,"statement_or_summary":164},"REYNOLDS BLEACHING PROCESS","Reynolds Laboratories","1979-04-10",{"items":329,"total":163},[]]