[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-EIR":3},{"classification":4,"mappedDevices":146,"similarCandidates":147,"relatedClassifications":220,"syncDates":428,"translation":435,"marketSummary":441,"recalls":455,"k510s":457,"pmas":464},{"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":141,"updated_at":142,"recall_count":143,"latest_recall_date":144,"k510_count":145,"pma_count":143,"event_count":145},1289,"EIR","Scissors, Collar And Crown","1","872.4565","DE","Dental","4","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":139,"product_code":6,"review_panel":10,"gmp_exempt_flag":139,"third_party_flag":139,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":139,"medical_specialty_description":11,"summary_malfunction_reporting":140},{"k_number":17,"fei_number":19,"registration_number":105},[18],"K851729",[20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,48,49,50,51,52,53,54,55,56,57,58,59,60,61,62,63,64,65,66,67,68,69,70,71,72,73,74,75,76,77,78,79,80,81,82,83,84,85,86,87,88,89,90,91,92,93,94,95,96,97,98,99,100,101,102,103,104],"3429","3003424264","3013547731","3002808360","3004193466","3003431869","2511556","2183301","3031841433","3003029409","3009142050","3003963832","1000127002","3004992978","1000405819","3002834291","3001000014","3011600579","3002750084","3007803626","3008770252","3008936260","3000183921","3003882387","3011371465","3002806315","2411056","3032747418","3005969827","3015176311","1000159990","3004784004","3003944071","3017352116","1000453845","3021666757","3014334038","3000219976","3002806755","3012101664","3002808335","2080222","1417592","3004001706","3005809810","3009340886","3008338766","3010442693","3546","3002806452","3042272797","3012421607","3008902714","3014937043","3002806930","3010699884","3003582728","3002806816","3035693034","3003005156","3003418325","5906","3002315844","3002807373","3002807183","3009171220","3000209941","3007773213","1419489","1416605","3003499455","2916714","3009968482","3014829979","3002291143","2018957","1000115048","3015398570","3016965929","3015156396","3008268830","3002769844","3002807169","3004216008","1000390051",[106,107,22,108,109,110,24,25,26,27,28,30,31,33,111,35,112,37,113,40,114,41,115,116,43,44,117,118,119,46,47,120,49,51,53,55,56,57,59,121,61,122,123,124,125,62,63,64,126,65,66,67,127,70,71,72,73,128,75,76,129,130,78,80,81,131,85,132,87,88,133,89,134,91,92,93,95,135,97,136,98,99,101,137,138],"9611502","9610809","9614986","9614062","9611367","1422507","9680515","2133714","9610612","9611385","9611503","8040278","9710524","9680260","8040881","8010732","8010159","9614069","1836161","9613083","9611283","9611062","1421879","8010665","8040233","8043554","3027616","8040179","8010168","1066741","2032006","3005067367","9614075","N","Eligible","2026-08-18T05:52:48.747665+00:00","2026-08-24T02:00:48.225237+00:00",0,null,1,[],[148,156,163,170,177,185,192,199,206,213],{"medical_device_id":149,"generic_name":150,"class_classification":151,"jmdn_code":152,"name_similarity":153,"definition_similarity":143,"vector_similarity":154,"score":155},4184,"歯科用金冠はさみ","Ⅰ","31847000",0.65625,0.793355,0.0327869,{"medical_device_id":157,"generic_name":158,"class_classification":151,"jmdn_code":159,"name_similarity":160,"definition_similarity":143,"vector_similarity":161,"score":162},4185,"はさみ","35325001",0.36,0.634062,0.032002,{"medical_device_id":164,"generic_name":165,"class_classification":151,"jmdn_code":166,"name_similarity":167,"definition_similarity":143,"vector_similarity":168,"score":169},4183,"歯科用歯肉はさみ","31822000",0.2,0.674252,0.0315136,{"medical_device_id":171,"generic_name":172,"class_classification":151,"jmdn_code":173,"name_similarity":174,"definition_similarity":143,"vector_similarity":175,"score":176},4186,"眼科用せん刀","35327001",0.25,0.621665,0.0310096,{"medical_device_id":178,"generic_name":179,"class_classification":180,"jmdn_code":181,"name_similarity":182,"definition_similarity":143,"vector_similarity":183,"score":184},2846,"単回使用はさみ","Ⅱ","35325002",0.257143,0.606457,0.0293865,{"medical_device_id":186,"generic_name":187,"class_classification":180,"jmdn_code":188,"name_similarity":189,"definition_similarity":143,"vector_similarity":190,"score":191},2721,"歯科用被覆冠成形品","70822000",0.142857,0.614754,0.0281385,{"medical_device_id":193,"generic_name":194,"class_classification":180,"jmdn_code":195,"name_similarity":196,"definition_similarity":143,"vector_similarity":197,"score":198},2847,"単回使用眼科用せん刀","35327002",0.195652,0.602823,0.0278097,{"medical_device_id":200,"generic_name":201,"class_classification":180,"jmdn_code":202,"name_similarity":203,"definition_similarity":143,"vector_similarity":204,"score":205},2893,"単回使用手術用クラウンドリルビット","37871002",0.132075,0.603354,0.0256452,{"medical_device_id":207,"generic_name":208,"class_classification":180,"jmdn_code":209,"name_similarity":210,"definition_similarity":143,"vector_similarity":211,"score":212},2702,"歯科用暫間被覆冠成形品","34976000",0.122449,0.589769,0.0230159,{"medical_device_id":214,"generic_name":215,"class_classification":151,"jmdn_code":216,"name_similarity":217,"definition_similarity":143,"vector_similarity":218,"score":219},3753,"再使用可能な結さつ・固定用クリップアプライヤ","70406000",0.0338983,0.623032,0.015625,[221,225,229,233,237,240,244,248,251,255,259,263,266,269,272,276,279,282,285,289,292,295,299,302,305,308,312,315,318,321,324,328,331,334,337,340,343,347,350,353,356,359,362,365,368,371,374,377,380,383,386,389,392,395,398,401,404,407,410,413,416,419,422,425],{"product_code":222,"device_name":223,"device_class":8,"k510_count":224},"EKJ","Burnisher, Operative",72,{"product_code":226,"device_name":227,"device_class":8,"k510_count":228},"EKS","File, Pulp Canal, Endodontic",31,{"product_code":230,"device_name":231,"device_class":8,"k510_count":232},"EIS","Remover, Crown",19,{"product_code":234,"device_name":235,"device_class":8,"k510_count":236},"DZN","Instruments, Dental Hand",16,{"product_code":238,"device_name":239,"device_class":8,"k510_count":236},"EIC","Syringe, Periodontic, Endodontic, Irrigating",{"product_code":241,"device_name":242,"device_class":8,"k510_count":243},"EID","Syringe, Restorative And Impression Material",13,{"product_code":245,"device_name":246,"device_class":8,"k510_count":247},"EAX","Mirror, Mouth",12,{"product_code":249,"device_name":250,"device_class":8,"k510_count":247},"ECB","Unit, Syringe, Air And\u002FOr Water",{"product_code":252,"device_name":253,"device_class":8,"k510_count":254},"EMG","Forceps, Tooth Extractor, Surgical",10,{"product_code":256,"device_name":257,"device_class":8,"k510_count":258},"EIX","Probe, Periodontic",9,{"product_code":260,"device_name":261,"device_class":8,"k510_count":262},"EIG","Retractor, All Types",8,{"product_code":264,"device_name":265,"device_class":8,"k510_count":262},"EIL","Gauge, Depth, Instrument, Dental",{"product_code":267,"device_name":268,"device_class":8,"k510_count":262},"EJB","Handle, Instrument, Dental",{"product_code":270,"device_name":271,"device_class":8,"k510_count":262},"EMH","Forceps, Rongeur, Surgical",{"product_code":273,"device_name":274,"device_class":8,"k510_count":275},"EGN","Scissors, Surgical Tissue, Dental",7,{"product_code":277,"device_name":278,"device_class":8,"k510_count":275},"EKW","Broach, Endodontic",{"product_code":280,"device_name":281,"device_class":8,"k510_count":275},"EMS","Curette, Periodontic",{"product_code":283,"device_name":284,"device_class":8,"k510_count":275},"JEX","Plier, Orthodontic",{"product_code":286,"device_name":287,"device_class":8,"k510_count":288},"EKP","Reamer, Pulp Canal, Endodontic",6,{"product_code":290,"device_name":291,"device_class":8,"k510_count":288},"EKR","Plugger, Root Canal, Endodontic",{"product_code":293,"device_name":294,"device_class":8,"k510_count":288},"EMJ","Elevator, Surgical, Dental",{"product_code":296,"device_name":297,"device_class":8,"k510_count":298},"EFL","Forceps, Dressing, Dental",5,{"product_code":300,"device_name":301,"device_class":8,"k510_count":298},"EIK","Carver, Wax, Dental",{"product_code":303,"device_name":304,"device_class":8,"k510_count":298},"EIY","Instrument, Filling, Plastic, Dental",{"product_code":306,"device_name":307,"device_class":8,"k510_count":298},"EMN","Scaler, Periodontic",{"product_code":309,"device_name":310,"device_class":8,"k510_count":311},"EIB","Syringe, Irrigating (Dental)",4,{"product_code":313,"device_name":314,"device_class":8,"k510_count":311},"EIF","Accessories, Retractor, Dental",{"product_code":316,"device_name":317,"device_class":8,"k510_count":311},"ELA","Instrument, Hand, Calculus Removal",{"product_code":319,"device_name":320,"device_class":8,"k510_count":311},"EMI","File, Bone, Surgical",{"product_code":322,"device_name":323,"device_class":8,"k510_count":311},"EMM","Chisel, Osteotome, Surgical",{"product_code":325,"device_name":326,"device_class":8,"k510_count":327},"ECR","Setter, Band, Orthodontic",3,{"product_code":329,"device_name":330,"device_class":8,"k510_count":327},"EKB","Explorer, Operative",{"product_code":332,"device_name":333,"device_class":8,"k510_count":327},"EKG","Condenser, Amalgam And Foil, Operative",{"product_code":335,"device_name":336,"device_class":8,"k510_count":327},"EKH","Carver, Dental Amalgam, Operative",{"product_code":338,"device_name":339,"device_class":8,"k510_count":327},"EME","Punch, Biopsy, Surgical",{"product_code":341,"device_name":342,"device_class":8,"k510_count":327},"JEP","Retainer, Matrix",{"product_code":344,"device_name":345,"device_class":8,"k510_count":346},"ECQ","Aligner, Bracket, Orthodontic",2,{"product_code":348,"device_name":349,"device_class":8,"k510_count":346},"ECS","Pusher, Band, Orthodontic",{"product_code":351,"device_name":352,"device_class":8,"k510_count":346},"EJY","Pliers, Operative",{"product_code":354,"device_name":355,"device_class":8,"k510_count":346},"EJZ","Knife, Margin Finishing, Operative",{"product_code":357,"device_name":358,"device_class":8,"k510_count":346},"EKA","File, Margin Finishing, Operative",{"product_code":360,"device_name":361,"device_class":8,"k510_count":346},"EKC","Excavator, Dental, Operative",{"product_code":363,"device_name":364,"device_class":8,"k510_count":346},"EKD","Instrument, Cutting, Operative",{"product_code":366,"device_name":367,"device_class":8,"k510_count":346},"EKI","Carrier, Amalgam, Operative",{"product_code":369,"device_name":370,"device_class":8,"k510_count":346},"EKQ","Preparer, Root Canal Endodontic",{"product_code":372,"device_name":373,"device_class":8,"k510_count":346},"EMD","Hemostat, Surgical",{"product_code":375,"device_name":376,"device_class":8,"k510_count":346},"EML","Chisel, Bone, Surgical",{"product_code":378,"device_name":379,"device_class":8,"k510_count":145},"EGI","Parallelometer",{"product_code":381,"device_name":382,"device_class":8,"k510_count":145},"EKK","Spreader, Pulp Canal Filling Material, Endodontic",{"product_code":384,"device_name":385,"device_class":8,"k510_count":145},"EMK","Curette, Surgical, Dental",{"product_code":387,"device_name":388,"device_class":8,"k510_count":145},"EMR","File, Periodontic",{"product_code":390,"device_name":391,"device_class":8,"k510_count":143},"ECP","Instrument, Ligature Tucking, Orthodontic",{"product_code":393,"device_name":394,"device_class":8,"k510_count":143},"ECT","Driver, Band, Orthodontic",{"product_code":396,"device_name":397,"device_class":8,"k510_count":143},"EFK","Forceps, Articulation Paper",{"product_code":399,"device_name":400,"device_class":8,"k510_count":143},"EKE","Curette, Operative",{"product_code":402,"device_name":403,"device_class":8,"k510_count":143},"EKF","Instrument, Contouring, Matrix, Operative",{"product_code":405,"device_name":406,"device_class":8,"k510_count":143},"EKT","Curette, Endodontic",{"product_code":408,"device_name":409,"device_class":8,"k510_count":143},"EMO","Knife, Periodontic",{"product_code":411,"device_name":412,"device_class":8,"k510_count":143},"EMP","Marker, Periodontic",{"product_code":414,"device_name":415,"device_class":8,"k510_count":143},"EMQ","Hoe, Periodontic",{"product_code":417,"device_name":418,"device_class":8,"k510_count":143},"NYC","Dental Prophylaxis Kit",{"product_code":420,"device_name":421,"device_class":8,"k510_count":143},"NYF","Gingival Retraction Kit",{"product_code":423,"device_name":424,"device_class":8,"k510_count":143},"NYG","Lapping Tool Kit",{"product_code":426,"device_name":427,"device_class":8,"k510_count":143},"PWL","Oral Surgery Tray",{"510k":429,"classification":430,"enforcement":431,"event":432,"pma":433,"warning_letter":434},"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":436,"definition_ja":144,"commentary_ja":437,"model_name":438,"source_hash":439,"reviewed_by":144,"reviewed_at":144,"created_at":440,"updated_at":440},"歯冠用剪刀","本機器は歯科領域において歯冠形成やカラー（頸部）部分の処置に用いられる剪刀（はさみ）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)）が免除される区分となっています。これは、リスクが低く、有効性・安全性を確保するための一般的な規制のみで足りると判断される機器であることを意味します。","claude-sonnet-5","94c5abf3115ce601b258e324976a87d0e93d7f16a7af212d738c5b71bfdfef90","2026-08-24T01:48:55.976021+00:00",{"product_code":6,"summary_ja":442,"stats":443,"stats_hash":453,"model_name":438,"created_at":454,"updated_at":454},"本製品コードでは、510(k)の累計件数は1件、参入企業数は1社となっており、直近5年間の届出はありません。不具合報告は累計1件で、内容はMalfunction(不具合)によるもので、死亡・傷害の報告は確認されていません。回収の実績は確認されていません。",{"pma":444,"k510":445,"as_of":447,"events":448,"recalls":450,"top_problems":452},{"latest":144,"originals":143,"supplements":143},{"total":145,"last5y":143,"latest":446,"applicants":145},"1985-07-02","2026-08",{"death":143,"other":143,"total":145,"injury":143,"last5y":143,"malfunction":145,"latest_month":449},"2011-10",{"total":143,"last5y":143,"latest":144,"class_i":143,"class_ii":143,"class_iii":143,"top_root_causes":451},[],[],"933a2556efd18ab6a693e5b73c508b803f475913c982471c0e28f4f1ab55864b","2026-08-24T04:17:09.731512+00:00",{"items":456,"total":143},[],{"items":458,"total":145},[459],{"k_number":18,"device_name":460,"applicant":461,"decision_date":446,"clearance_type":462,"decision_code":463,"statement_or_summary":144},"2620\u002F1 TO 2635\u002F2 VARIOUS DENTAL CROWN SCISSORS","Artiberia","Traditional","SESE",{"items":465,"total":143},[]]