[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EMH":3},{"classification":4,"mappedDevices":267,"similarCandidates":268,"relatedClassifications":341,"syncDates":549,"translation":556,"marketSummary":562,"recalls":576,"k510s":578,"pmas":611},{"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":261,"updated_at":262,"recall_count":263,"latest_recall_date":264,"k510_count":265,"pma_count":263,"event_count":266},4825,"EMH","Forceps, Rongeur, Surgical","1","872.4565","DE","Dental","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":259,"product_code":6,"review_panel":10,"gmp_exempt_flag":259,"third_party_flag":259,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":259,"medical_specialty_description":11,"summary_malfunction_reporting":260},{"k_number":17,"fei_number":26,"registration_number":193},[18,19,20,21,22,23,24,25],"K851710","K821358","K834366","K890255","K890256","K834190","K854887","K771522",[13,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152,153,154,155,156,157,158,159,160,161,162,163,164,165,166,167,168,169,170,171,172,173,174,175,176,177,178,179,180,181,182,183,184,185,186,187,188,189,190,191,192],"3003244954","3429","3004425647","1000443015","1828464","3006487092","3002808360","3014615697","3019455","3006142527","3003772581","3003052153","3000041196","1032227","3005734757","3001146947","3004193466","1000555370","3003431869","2511556","2183301","3009465247","3004207793","3003963832","3009756153","1720747","3002834291","3008808049","3001000014","3013273457","3002807418","1000160732","3016894896","3002750084","3003988575","3002806575","3007803626","3008770252","3030644259","3003759558","3008936260","3005061536","3007648354","3000183921","3005695838","3002786339","3000286616","3003882387","3001620590","1000160162","3003877407","3003644849","3031564283","3003697160","3003120666","3004216008","3002806773","3030643611","3002806315","3002807988","3001644167","3004608878","3008782585","3032747418","3007064566","3005969827","3013358456","3014683120","3000280067","3010041511","3003944071","3017352116","1000453845","3001032747","6082","1000208866","3010399422","3021666757","3005587147","3014334038","3005813597","1412854","3014004349","3012101664","3002808270","1032347","3043625057","3006509795","3002808335","3012226300","2080222","3005440795","3002807010","3009718267","3010055973","3005528784","1417592","3013846070","3005621335","3005809810","1000402972","3009340886","3002806862","3008338766","3002807115","3546","3012421607","3008902714","3002808043","3014937043","3002761766","3002809535","3004975279","3004552850","1000179044","1000111204","3005595283","3045811395","4498","3002806816","1000127001","3003445992","3003005156","3003418325","5906","3002315844","3004215117","3002807373","3002807183","3002807214","3009171220","3015393204","3007773213","1421101","3005515228","3002807754","1419489","1416605","3002807318","1000194896","3003499455","2916714","3009968482","3014829979","3003914946","2424531","1000306694","3003882399","3004049923","3002291143","7282","1000115048","3003969055","3015398570","1220246","3016965929","3015156396","3008268830","3002769844","3035708926","3002807169","3013503739","3015397788","3005747797","1000390051","1000140363",[13,27,194,29,31,195,32,196,197,34,35,198,36,199,40,200,201,42,43,45,46,202,47,48,203,50,51,52,53,54,204,56,205,59,61,206,64,207,208,65,66,67,209,69,68,210,71,211,212,73,74,213,75,77,214,78,79,215,81,216,217,218,219,220,84,87,88,90,91,93,221,94,222,96,98,103,104,105,106,107,108,109,110,111,112,113,223,116,224,225,226,117,227,118,228,229,230,120,121,122,231,232,124,123,233,125,126,234,235,236,128,130,131,237,133,134,136,137,238,239,140,240,241,242,143,144,243,244,245,150,151,153,246,157,158,247,159,160,161,163,164,248,168,249,169,250,170,251,172,252,174,175,253,254,179,255,180,181,256,182,183,185,186,257,188,189,258],"9610809","9680026","8040263","8043988","8010257","9614062","9611367","9680059","8043769","9616246","9680515","3027615","9611450","9610612","8043507","1056350","1055890","2087382","9611503","9613926","8010769","9611814","8040278","9611274","9710524","9680260","2132732","8040881","8043368","9613079","8010732","9612086","9680718","8010159","9614069","1836161","9614945","9613083","9616250","9612278","8043816","9611283","3011137372","9611062","9616119","8010704","1421879","8043496","2085199","8040233","1646747","9613348","8043554","2249529","8010168","9611390","9614404","8044057","8010269","8030607","1066741","2248030","9611112","3005067367","9614075","N","Eligible","2026-08-18T05:52:52.082407+00:00","2026-08-24T02:00:48.225237+00:00",0,null,8,25,[],[269,277,284,291,298,305,312,320,327,334],{"medical_device_id":270,"generic_name":271,"class_classification":272,"jmdn_code":273,"name_similarity":274,"definition_similarity":263,"vector_similarity":275,"score":276},4232,"手術用骨鉗子","Ⅰ","32853000",0.68,0.779693,0.0327869,{"medical_device_id":278,"generic_name":279,"class_classification":272,"jmdn_code":280,"name_similarity":281,"definition_similarity":263,"vector_similarity":282,"score":283},4234,"結石除去用鉗子","35083000",0.305556,0.744482,0.03031,{"medical_device_id":285,"generic_name":286,"class_classification":272,"jmdn_code":287,"name_similarity":288,"definition_similarity":263,"vector_similarity":289,"score":290},4224,"ピンセット","35079001",0.32,0.736704,0.030303,{"medical_device_id":292,"generic_name":293,"class_classification":272,"jmdn_code":294,"name_similarity":295,"definition_similarity":263,"vector_similarity":296,"score":297},4227,"鉗子","10861001",0.272727,0.77381,0.029116,{"medical_device_id":299,"generic_name":300,"class_classification":272,"jmdn_code":301,"name_similarity":302,"definition_similarity":263,"vector_similarity":303,"score":304},4236,"歯科技工用鉗子","70935000",0.395349,0.697972,0.0287873,{"medical_device_id":306,"generic_name":307,"class_classification":272,"jmdn_code":308,"name_similarity":309,"definition_similarity":263,"vector_similarity":310,"score":311},4226,"扁桃腺用鉗子","15672000",0.25,0.731887,0.026289,{"medical_device_id":313,"generic_name":314,"class_classification":315,"jmdn_code":316,"name_similarity":317,"definition_similarity":263,"vector_similarity":318,"score":319},2264,"手術用タンプ","Ⅱ","32873000",0.3,0.644848,0.0258564,{"medical_device_id":321,"generic_name":322,"class_classification":272,"jmdn_code":323,"name_similarity":324,"definition_similarity":263,"vector_similarity":325,"score":326},4230,"歯科用骨鉗子","15713000",0.290323,0.6752,0.0255168,{"medical_device_id":328,"generic_name":329,"class_classification":315,"jmdn_code":330,"name_similarity":331,"definition_similarity":263,"vector_similarity":332,"score":333},2861,"単回使用ピンセット","35079002",0.257143,0.69567,0.0246914,{"medical_device_id":335,"generic_name":336,"class_classification":272,"jmdn_code":337,"name_similarity":338,"definition_similarity":263,"vector_similarity":339,"score":340},4235,"抜歯用鉗子","35552000",0.214286,0.763941,0.015873,[342,346,350,354,358,361,365,369,372,376,380,383,386,389,393,396,399,402,406,409,412,416,419,422,425,429,432,435,438,441,445,448,451,454,457,460,464,467,470,473,476,479,482,485,488,491,494,498,501,504,507,510,513,516,519,522,525,528,531,534,537,540,543,546],{"product_code":343,"device_name":344,"device_class":8,"k510_count":345},"EKJ","Burnisher, Operative",72,{"product_code":347,"device_name":348,"device_class":8,"k510_count":349},"EKS","File, Pulp Canal, Endodontic",31,{"product_code":351,"device_name":352,"device_class":8,"k510_count":353},"EIS","Remover, Crown",19,{"product_code":355,"device_name":356,"device_class":8,"k510_count":357},"DZN","Instruments, Dental Hand",16,{"product_code":359,"device_name":360,"device_class":8,"k510_count":357},"EIC","Syringe, Periodontic, Endodontic, Irrigating",{"product_code":362,"device_name":363,"device_class":8,"k510_count":364},"EID","Syringe, Restorative And Impression Material",13,{"product_code":366,"device_name":367,"device_class":8,"k510_count":368},"EAX","Mirror, Mouth",12,{"product_code":370,"device_name":371,"device_class":8,"k510_count":368},"ECB","Unit, Syringe, Air And\u002FOr Water",{"product_code":373,"device_name":374,"device_class":8,"k510_count":375},"EMG","Forceps, Tooth Extractor, Surgical",10,{"product_code":377,"device_name":378,"device_class":8,"k510_count":379},"EIX","Probe, Periodontic",9,{"product_code":381,"device_name":382,"device_class":8,"k510_count":265},"EIG","Retractor, All Types",{"product_code":384,"device_name":385,"device_class":8,"k510_count":265},"EIL","Gauge, Depth, Instrument, Dental",{"product_code":387,"device_name":388,"device_class":8,"k510_count":265},"EJB","Handle, Instrument, Dental",{"product_code":390,"device_name":391,"device_class":8,"k510_count":392},"EGN","Scissors, Surgical Tissue, Dental",7,{"product_code":394,"device_name":395,"device_class":8,"k510_count":392},"EKW","Broach, Endodontic",{"product_code":397,"device_name":398,"device_class":8,"k510_count":392},"EMS","Curette, Periodontic",{"product_code":400,"device_name":401,"device_class":8,"k510_count":392},"JEX","Plier, Orthodontic",{"product_code":403,"device_name":404,"device_class":8,"k510_count":405},"EKP","Reamer, Pulp Canal, Endodontic",6,{"product_code":407,"device_name":408,"device_class":8,"k510_count":405},"EKR","Plugger, Root Canal, Endodontic",{"product_code":410,"device_name":411,"device_class":8,"k510_count":405},"EMJ","Elevator, Surgical, Dental",{"product_code":413,"device_name":414,"device_class":8,"k510_count":415},"EFL","Forceps, Dressing, Dental",5,{"product_code":417,"device_name":418,"device_class":8,"k510_count":415},"EIK","Carver, Wax, Dental",{"product_code":420,"device_name":421,"device_class":8,"k510_count":415},"EIY","Instrument, Filling, Plastic, Dental",{"product_code":423,"device_name":424,"device_class":8,"k510_count":415},"EMN","Scaler, Periodontic",{"product_code":426,"device_name":427,"device_class":8,"k510_count":428},"EIB","Syringe, Irrigating (Dental)",4,{"product_code":430,"device_name":431,"device_class":8,"k510_count":428},"EIF","Accessories, Retractor, Dental",{"product_code":433,"device_name":434,"device_class":8,"k510_count":428},"ELA","Instrument, Hand, Calculus Removal",{"product_code":436,"device_name":437,"device_class":8,"k510_count":428},"EMI","File, Bone, Surgical",{"product_code":439,"device_name":440,"device_class":8,"k510_count":428},"EMM","Chisel, Osteotome, Surgical",{"product_code":442,"device_name":443,"device_class":8,"k510_count":444},"ECR","Setter, Band, Orthodontic",3,{"product_code":446,"device_name":447,"device_class":8,"k510_count":444},"EKB","Explorer, Operative",{"product_code":449,"device_name":450,"device_class":8,"k510_count":444},"EKG","Condenser, Amalgam And Foil, Operative",{"product_code":452,"device_name":453,"device_class":8,"k510_count":444},"EKH","Carver, Dental Amalgam, Operative",{"product_code":455,"device_name":456,"device_class":8,"k510_count":444},"EME","Punch, Biopsy, Surgical",{"product_code":458,"device_name":459,"device_class":8,"k510_count":444},"JEP","Retainer, Matrix",{"product_code":461,"device_name":462,"device_class":8,"k510_count":463},"ECQ","Aligner, Bracket, Orthodontic",2,{"product_code":465,"device_name":466,"device_class":8,"k510_count":463},"ECS","Pusher, Band, Orthodontic",{"product_code":468,"device_name":469,"device_class":8,"k510_count":463},"EJY","Pliers, Operative",{"product_code":471,"device_name":472,"device_class":8,"k510_count":463},"EJZ","Knife, Margin Finishing, Operative",{"product_code":474,"device_name":475,"device_class":8,"k510_count":463},"EKA","File, Margin Finishing, Operative",{"product_code":477,"device_name":478,"device_class":8,"k510_count":463},"EKC","Excavator, Dental, Operative",{"product_code":480,"device_name":481,"device_class":8,"k510_count":463},"EKD","Instrument, Cutting, Operative",{"product_code":483,"device_name":484,"device_class":8,"k510_count":463},"EKI","Carrier, Amalgam, Operative",{"product_code":486,"device_name":487,"device_class":8,"k510_count":463},"EKQ","Preparer, Root Canal Endodontic",{"product_code":489,"device_name":490,"device_class":8,"k510_count":463},"EMD","Hemostat, Surgical",{"product_code":492,"device_name":493,"device_class":8,"k510_count":463},"EML","Chisel, Bone, Surgical",{"product_code":495,"device_name":496,"device_class":8,"k510_count":497},"EGI","Parallelometer",1,{"product_code":499,"device_name":500,"device_class":8,"k510_count":497},"EIR","Scissors, Collar And Crown",{"product_code":502,"device_name":503,"device_class":8,"k510_count":497},"EKK","Spreader, Pulp Canal Filling Material, Endodontic",{"product_code":505,"device_name":506,"device_class":8,"k510_count":497},"EMK","Curette, Surgical, Dental",{"product_code":508,"device_name":509,"device_class":8,"k510_count":497},"EMR","File, Periodontic",{"product_code":511,"device_name":512,"device_class":8,"k510_count":263},"ECP","Instrument, Ligature Tucking, Orthodontic",{"product_code":514,"device_name":515,"device_class":8,"k510_count":263},"ECT","Driver, Band, Orthodontic",{"product_code":517,"device_name":518,"device_class":8,"k510_count":263},"EFK","Forceps, Articulation Paper",{"product_code":520,"device_name":521,"device_class":8,"k510_count":263},"EKE","Curette, Operative",{"product_code":523,"device_name":524,"device_class":8,"k510_count":263},"EKF","Instrument, Contouring, Matrix, Operative",{"product_code":526,"device_name":527,"device_class":8,"k510_count":263},"EKT","Curette, Endodontic",{"product_code":529,"device_name":530,"device_class":8,"k510_count":263},"EMO","Knife, Periodontic",{"product_code":532,"device_name":533,"device_class":8,"k510_count":263},"EMP","Marker, Periodontic",{"product_code":535,"device_name":536,"device_class":8,"k510_count":263},"EMQ","Hoe, Periodontic",{"product_code":538,"device_name":539,"device_class":8,"k510_count":263},"NYC","Dental Prophylaxis Kit",{"product_code":541,"device_name":542,"device_class":8,"k510_count":263},"NYF","Gingival Retraction Kit",{"product_code":544,"device_name":545,"device_class":8,"k510_count":263},"NYG","Lapping Tool Kit",{"product_code":547,"device_name":548,"device_class":8,"k510_count":263},"PWL","Oral Surgery Tray",{"510k":550,"classification":551,"enforcement":552,"event":553,"pma":554,"warning_letter":555},"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":557,"definition_ja":264,"commentary_ja":558,"model_name":559,"source_hash":560,"reviewed_by":264,"reviewed_at":264,"created_at":561,"updated_at":561},"外科用ロンジュール鉗子","本品は米国FDAの規制分類においてクラスIに該当する医療機器です。クラスIは一般規制のみが適用される最も規制の低い区分であり、本品は市販前届出（510(k)）が免除されているため、FDAへの届出を行うことなく市販することが可能です。","claude-sonnet-5","410d3a55e7c2ec975209b91a6adf530ac5a88d8221e6fde6ad052a031fd2aeed","2026-08-24T01:50:05.227637+00:00",{"product_code":6,"summary_ja":563,"stats":564,"stats_hash":574,"model_name":559,"created_at":575,"updated_at":575},"510(k)の累計届出は約8件で、参入企業は7社となっていますが、直近5年間の届出は確認されていません。不具合報告は累計約25件で、内訳は不具合（Malfunction）が約13件、傷害が8件、その他が4件となっており、死亡報告は0件です。直近5年間の報告はなく、最新の報告は2021年3月となっています。回収については累計0件で、クラスI・II・IIIいずれも確認されていません。",{"pma":565,"k510":566,"as_of":568,"events":569,"recalls":571,"top_problems":573},{"latest":264,"originals":263,"supplements":263},{"total":265,"last5y":263,"latest":567,"applicants":392},"1989-01-27","2026-08",{"death":263,"other":428,"total":266,"injury":265,"last5y":263,"malfunction":364,"latest_month":570},"2021-03",{"total":263,"last5y":263,"latest":264,"class_i":263,"class_ii":263,"class_iii":263,"top_root_causes":572},[],[],"a10c8400bef357e93f0afb6e888f881a244904882d236c6c07f09b7e4bd65be2","2026-08-24T04:18:34.328284+00:00",{"items":577,"total":263},[],{"items":579,"total":265},[580,585,587,591,595,599,603,607],{"k_number":22,"device_name":581,"applicant":582,"decision_date":567,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"BONE RONGEUR, DOUBLE-ACTION","Kinetic Medical Products","Traditional","SESE",{"k_number":21,"device_name":586,"applicant":582,"decision_date":567,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"BONE RONGEUR, SINGLE-ACTION",{"k_number":24,"device_name":588,"applicant":589,"decision_date":590,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"MANU\u002FSURG INST\u002FACCESS WUERZBURG TIT MINI BONE PLAT","Walter Lorenz Surgical, Inc.","1986-02-28",{"k_number":18,"device_name":592,"applicant":593,"decision_date":594,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"586 TO 596 VARIOUS TYPES DENTAL ROOT SPLINTER FORC","Artiberia","1985-06-11",{"k_number":23,"device_name":596,"applicant":597,"decision_date":598,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"JAKOBI SURG. INSTRUMENTS #8 15","Imm Enterprises , Ltd.","1984-03-06",{"k_number":20,"device_name":600,"applicant":601,"decision_date":602,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"SURGICAL INSTRUMENTS & ACCESSORIES","C.B.S. Biotechnics, Inc.","1984-02-27",{"k_number":19,"device_name":604,"applicant":605,"decision_date":606,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"MODIFIED RONGEURS FOR SPINAL & ORTH. S.","Downs Surgical , Ltd.","1982-05-28",{"k_number":25,"device_name":608,"applicant":609,"decision_date":610,"clearance_type":583,"decision_code":584,"statement_or_summary":264},"FORCEPS, STYLE #849","Premier Dental Products Co.","1977-08-16",{"items":612,"total":263},[]]