[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EMM":3},{"classification":4,"mappedDevices":223,"similarCandidates":224,"relatedClassifications":296,"syncDates":502},{"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":216,"updated_at":217,"recall_count":218,"latest_recall_date":219,"k510_count":220,"pma_count":221,"event_count":222},4345,"EMM","Chisel, Osteotome, Surgical","1","872.4565","DE","Dental","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":214,"product_code":6,"review_panel":10,"gmp_exempt_flag":214,"third_party_flag":214,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":214,"medical_specialty_description":11,"summary_malfunction_reporting":215},{"k_number":17,"fei_number":22,"registration_number":153},[18,19,20,21],"K851714","K864775","K760959","K963897",[13,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104,105,106,107,108,109,110,111,112,113,114,115,116,117,118,119,120,121,122,123,124,125,126,127,128,129,130,131,132,133,134,135,136,137,138,139,140,141,142,143,144,145,146,147,148,149,150,151,152],"3005349543","3002806822","3003424264","3022862651","1000443015","3006487092","3004028763","3003772581","3003052153","1032227","1000114355","3025338240","2523865","4460","2511556","3015895045","3003963832","3004095748","1000405819","1720747","3002834291","3008808049","1923569","3007283751","3001000014","3011600579","1000160732","3002750084","3002806575","3007803626","3008770252","3006554912","1000168975","3030644259","3007648354","3000183921","1000136191","3002902165","3002786339","3000286616","3003882387","1000160162","3003877407","3003697160","3013111692","3011824442","3004216008","3008261720","3002806315","3002806355","1926681","5870","3001644167","3010687973","3008496301","3007064566","3005969827","1000159990","3010041511","3000280067","3017352116","3001032747","4224","3008237805","3021666757","3043047788","3012101664","3002808270","1032347","4476","3006509795","1219619","3002648735","3012226300","3036795921","2080222","3005440795","3010055973","3005528784","1417592","3008711893","1219518","3005621335","1000525271","1000402972","3003038445","3009340886","2434839","3008338766","3546","3009049852","3008902714","3007126709","3004975279","3030671632","3007878094","1828288","3029082594","3045811395","3001408183","3002806816","1000127001","3003005156","3004215117","1000305589","3007515069","3002807214","3009171220","3004578807","3002809480","3007290840","3007773213","1421101","3002807009","3003200061","3002807318","3002807464","2916714","7282","3002806429","1000115048","3015398570","3016965929","3002808264","3015156396","3002769844","3002807169","3005747797","1000390051","1000140363",[13,154,26,28,155,156,157,158,159,32,160,34,161,37,38,162,39,163,42,164,43,44,45,46,165,166,48,167,53,54,168,56,169,170,57,171,62,63,172,65,173,174,67,68,175,70,73,75,76,176,77,78,81,83,177,87,88,89,90,91,178,94,96,179,97,180,181,98,182,99,183,184,185,186,100,101,102,187,103,104,105,188,189,190,191,108,109,110,111,192,113,114,193,194,195,115,117,196,118,119,120,197,121,122,198,199,200,126,201,128,202,130,131,203,134,135,204,140,205,206,207,144,145,147,208,148,209,210,211,212,213],"1054986","9680026","9614986","9611278","8010099","9614062","9611367","8010252","9616246","9613866","1422507","1057946","9680515","3027615","9610612","9611262","1056350","2087382","9613926","8010769","8010300","8040278","2431166","1223843","9613079","9612086","9612075","8010732","9680718","8010159","1836161","9611461","9616250","9680244","9681851","8010155","9611283","3011137372","9610905","8010372","9616119","9612468","1421879","2085199","8010665","1646747","9613348","8010547","8043554","2249529","2529846","9614404","8030607","1066741","8010433","3005067367","8020776","9680735","8044098","1424478","N","Eligible","2026-08-18T05:52:51.740364+00:00","2026-08-18T22:05:38.961415+00:00",1,null,4,0,2,[],[225,233,240,246,254,261,268,274,282,288],{"medical_device_id":226,"generic_name":227,"class_classification":228,"jmdn_code":229,"name_similarity":230,"definition_similarity":221,"vector_similarity":231,"score":232},4173,"骨刀","Ⅰ","12844000",0.277778,0.777718,0.0306218,{"medical_device_id":234,"generic_name":235,"class_classification":228,"jmdn_code":236,"name_similarity":237,"definition_similarity":221,"vector_similarity":238,"score":239},4195,"のみ","10824000",0.269231,0.785686,0.0293805,{"medical_device_id":241,"generic_name":242,"class_classification":228,"jmdn_code":243,"name_similarity":230,"definition_similarity":221,"vector_similarity":244,"score":245},4321,"外科手術用骨クランプ","34949000",0.627744,0.0260504,{"medical_device_id":247,"generic_name":248,"class_classification":249,"jmdn_code":250,"name_similarity":251,"definition_similarity":221,"vector_similarity":252,"score":253},2239,"手術用クリップ","Ⅱ","37406000",0.333333,0.550068,0.0163934,{"medical_device_id":255,"generic_name":256,"class_classification":228,"jmdn_code":257,"name_similarity":258,"definition_similarity":221,"vector_similarity":259,"score":260},4268,"鈎","35105000",0.322581,0.54794,0.016129,{"medical_device_id":262,"generic_name":263,"class_classification":228,"jmdn_code":264,"name_similarity":265,"definition_similarity":221,"vector_similarity":266,"score":267},4174,"強膜刀","13507001",0.15625,0.690578,0.015873,{"medical_device_id":269,"generic_name":270,"class_classification":228,"jmdn_code":271,"name_similarity":272,"definition_similarity":221,"vector_similarity":273,"score":267},4190,"手術用のこぎり","13448001",0.310345,0.550536,{"medical_device_id":275,"generic_name":276,"class_classification":277,"jmdn_code":278,"name_similarity":279,"definition_similarity":221,"vector_similarity":280,"score":281},322,"開頭手術用ドリル","Ⅳ","44404000",0.3,0.579884,0.015625,{"medical_device_id":283,"generic_name":284,"class_classification":228,"jmdn_code":285,"name_similarity":286,"definition_similarity":221,"vector_similarity":287,"score":281},4334,"骨手術用器械","70962001",0.0677966,0.682056,{"medical_device_id":289,"generic_name":290,"class_classification":291,"jmdn_code":292,"name_similarity":293,"definition_similarity":221,"vector_similarity":294,"score":295},514,"手術用メッシュ","Ⅲ","16048003",0.290323,0.580987,0.0153846,[297,301,305,309,313,316,320,324,327,331,335,339,342,345,348,352,355,358,361,365,368,371,375,378,381,384,387,390,393,396,400,403,406,409,412,415,418,421,424,427,430,433,436,439,442,445,448,451,454,457,460,463,466,469,472,475,478,481,484,487,490,493,496,499],{"product_code":298,"device_name":299,"device_class":8,"k510_count":300},"EKJ","Burnisher, Operative",72,{"product_code":302,"device_name":303,"device_class":8,"k510_count":304},"EKS","File, Pulp Canal, Endodontic",31,{"product_code":306,"device_name":307,"device_class":8,"k510_count":308},"EIS","Remover, Crown",19,{"product_code":310,"device_name":311,"device_class":8,"k510_count":312},"DZN","Instruments, Dental Hand",16,{"product_code":314,"device_name":315,"device_class":8,"k510_count":312},"EIC","Syringe, Periodontic, Endodontic, Irrigating",{"product_code":317,"device_name":318,"device_class":8,"k510_count":319},"EID","Syringe, Restorative And Impression Material",13,{"product_code":321,"device_name":322,"device_class":8,"k510_count":323},"EAX","Mirror, Mouth",12,{"product_code":325,"device_name":326,"device_class":8,"k510_count":323},"ECB","Unit, Syringe, Air And\u002FOr Water",{"product_code":328,"device_name":329,"device_class":8,"k510_count":330},"EMG","Forceps, Tooth Extractor, Surgical",10,{"product_code":332,"device_name":333,"device_class":8,"k510_count":334},"EIX","Probe, Periodontic",9,{"product_code":336,"device_name":337,"device_class":8,"k510_count":338},"EIG","Retractor, All Types",8,{"product_code":340,"device_name":341,"device_class":8,"k510_count":338},"EIL","Gauge, Depth, Instrument, Dental",{"product_code":343,"device_name":344,"device_class":8,"k510_count":338},"EJB","Handle, Instrument, Dental",{"product_code":346,"device_name":347,"device_class":8,"k510_count":338},"EMH","Forceps, Rongeur, Surgical",{"product_code":349,"device_name":350,"device_class":8,"k510_count":351},"EGN","Scissors, Surgical Tissue, Dental",7,{"product_code":353,"device_name":354,"device_class":8,"k510_count":351},"EKW","Broach, Endodontic",{"product_code":356,"device_name":357,"device_class":8,"k510_count":351},"EMS","Curette, Periodontic",{"product_code":359,"device_name":360,"device_class":8,"k510_count":351},"JEX","Plier, Orthodontic",{"product_code":362,"device_name":363,"device_class":8,"k510_count":364},"EKP","Reamer, Pulp Canal, Endodontic",6,{"product_code":366,"device_name":367,"device_class":8,"k510_count":364},"EKR","Plugger, Root Canal, Endodontic",{"product_code":369,"device_name":370,"device_class":8,"k510_count":364},"EMJ","Elevator, Surgical, Dental",{"product_code":372,"device_name":373,"device_class":8,"k510_count":374},"EFL","Forceps, Dressing, Dental",5,{"product_code":376,"device_name":377,"device_class":8,"k510_count":374},"EIK","Carver, Wax, Dental",{"product_code":379,"device_name":380,"device_class":8,"k510_count":374},"EIY","Instrument, Filling, Plastic, Dental",{"product_code":382,"device_name":383,"device_class":8,"k510_count":374},"EMN","Scaler, Periodontic",{"product_code":385,"device_name":386,"device_class":8,"k510_count":220},"EIB","Syringe, Irrigating (Dental)",{"product_code":388,"device_name":389,"device_class":8,"k510_count":220},"EIF","Accessories, Retractor, Dental",{"product_code":391,"device_name":392,"device_class":8,"k510_count":220},"ELA","Instrument, Hand, Calculus Removal",{"product_code":394,"device_name":395,"device_class":8,"k510_count":220},"EMI","File, Bone, Surgical",{"product_code":397,"device_name":398,"device_class":8,"k510_count":399},"ECR","Setter, Band, Orthodontic",3,{"product_code":401,"device_name":402,"device_class":8,"k510_count":399},"EKB","Explorer, Operative",{"product_code":404,"device_name":405,"device_class":8,"k510_count":399},"EKG","Condenser, Amalgam And Foil, Operative",{"product_code":407,"device_name":408,"device_class":8,"k510_count":399},"EKH","Carver, Dental Amalgam, Operative",{"product_code":410,"device_name":411,"device_class":8,"k510_count":399},"EME","Punch, Biopsy, Surgical",{"product_code":413,"device_name":414,"device_class":8,"k510_count":399},"JEP","Retainer, Matrix",{"product_code":416,"device_name":417,"device_class":8,"k510_count":222},"ECQ","Aligner, Bracket, Orthodontic",{"product_code":419,"device_name":420,"device_class":8,"k510_count":222},"ECS","Pusher, Band, Orthodontic",{"product_code":422,"device_name":423,"device_class":8,"k510_count":222},"EJY","Pliers, Operative",{"product_code":425,"device_name":426,"device_class":8,"k510_count":222},"EJZ","Knife, Margin Finishing, Operative",{"product_code":428,"device_name":429,"device_class":8,"k510_count":222},"EKA","File, Margin Finishing, Operative",{"product_code":431,"device_name":432,"device_class":8,"k510_count":222},"EKC","Excavator, Dental, Operative",{"product_code":434,"device_name":435,"device_class":8,"k510_count":222},"EKD","Instrument, Cutting, Operative",{"product_code":437,"device_name":438,"device_class":8,"k510_count":222},"EKI","Carrier, Amalgam, Operative",{"product_code":440,"device_name":441,"device_class":8,"k510_count":222},"EKQ","Preparer, Root Canal Endodontic",{"product_code":443,"device_name":444,"device_class":8,"k510_count":222},"EMD","Hemostat, Surgical",{"product_code":446,"device_name":447,"device_class":8,"k510_count":222},"EML","Chisel, Bone, Surgical",{"product_code":449,"device_name":450,"device_class":8,"k510_count":218},"EGI","Parallelometer",{"product_code":452,"device_name":453,"device_class":8,"k510_count":218},"EIR","Scissors, Collar And Crown",{"product_code":455,"device_name":456,"device_class":8,"k510_count":218},"EKK","Spreader, Pulp Canal Filling Material, Endodontic",{"product_code":458,"device_name":459,"device_class":8,"k510_count":218},"EMK","Curette, Surgical, Dental",{"product_code":461,"device_name":462,"device_class":8,"k510_count":218},"EMR","File, Periodontic",{"product_code":464,"device_name":465,"device_class":8,"k510_count":221},"ECP","Instrument, Ligature Tucking, Orthodontic",{"product_code":467,"device_name":468,"device_class":8,"k510_count":221},"ECT","Driver, Band, Orthodontic",{"product_code":470,"device_name":471,"device_class":8,"k510_count":221},"EFK","Forceps, Articulation Paper",{"product_code":473,"device_name":474,"device_class":8,"k510_count":221},"EKE","Curette, Operative",{"product_code":476,"device_name":477,"device_class":8,"k510_count":221},"EKF","Instrument, Contouring, Matrix, Operative",{"product_code":479,"device_name":480,"device_class":8,"k510_count":221},"EKT","Curette, Endodontic",{"product_code":482,"device_name":483,"device_class":8,"k510_count":221},"EMO","Knife, Periodontic",{"product_code":485,"device_name":486,"device_class":8,"k510_count":221},"EMP","Marker, Periodontic",{"product_code":488,"device_name":489,"device_class":8,"k510_count":221},"EMQ","Hoe, Periodontic",{"product_code":491,"device_name":492,"device_class":8,"k510_count":221},"NYC","Dental Prophylaxis Kit",{"product_code":494,"device_name":495,"device_class":8,"k510_count":221},"NYF","Gingival Retraction Kit",{"product_code":497,"device_name":498,"device_class":8,"k510_count":221},"NYG","Lapping Tool Kit",{"product_code":500,"device_name":501,"device_class":8,"k510_count":221},"PWL","Oral Surgery Tray",{"510k":503,"classification":504,"enforcement":505,"event":506,"pma":507,"warning_letter":508},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:29:12.941+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]