[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NYH":3},{"classification":4,"mappedDevices":53,"similarCandidates":54,"relatedClassifications":137,"syncDates":142,"translation":149,"marketSummary":156,"recalls":170,"k510s":172,"pmas":179},{"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":48,"updated_at":49,"recall_count":50,"latest_recall_date":51,"k510_count":52,"pma_count":50,"event_count":52},2650,"NYH","Plaque Disclosing Kit","2","872.1740","DE","Dental","7","This product code has been established in accordance with the May 20, 1997, Guidance entitled, Convenience Kits Interim Regulatory Guidance, found at www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.html.  This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance.",false,{"openfda":16,"definition":13,"device_name":7,"review_code":45,"device_class":8,"implant_flag":46,"product_code":6,"review_panel":10,"gmp_exempt_flag":46,"third_party_flag":46,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":45,"life_sustain_support_flag":46,"medical_specialty_description":11,"summary_malfunction_reporting":47},{"k_number":17,"fei_number":19,"registration_number":37},[18],"K781919",[20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36],"3011215096","3015527463","1937310","3004536551","3002808289","1000523896","3004111573","3002902735","1643817","1000512168","3008648418","3001236905","3007329020","3004084693","3003941201","3009888344","3006542438",[20,21,22,26,38,39,28,40,30,41,32,34,35,36,42,43,44],"1423537","9615782","3029780","8044015","9612300","9616088","1061124","","N","Eligible","2026-08-18T05:52:50.495594+00:00","2026-08-24T02:00:49.169481+00:00",0,null,1,[],[55,64,72,81,89,97,106,114,122,129],{"medical_device_id":56,"generic_name":57,"class_classification":58,"jmdn_code":59,"name_similarity":60,"definition_similarity":61,"vector_similarity":62,"score":63},2648,"歯科用メッキ装置キット","Ⅱ","70761000",0.322581,0.0981818,0.632108,0.0310993,{"medical_device_id":65,"generic_name":66,"class_classification":58,"jmdn_code":67,"name_similarity":68,"definition_similarity":69,"vector_similarity":70,"score":71},2307,"単回使用吸引キット","36142000",0.157895,0.155779,0.623422,0.0281746,{"medical_device_id":73,"generic_name":74,"class_classification":75,"jmdn_code":76,"name_similarity":77,"definition_similarity":78,"vector_similarity":79,"score":80},1026,"医薬品含有歯科用象牙質接着材キット","Ⅲ","70866003",0.134615,0.149682,0.642271,0.0277571,{"medical_device_id":82,"generic_name":83,"class_classification":58,"jmdn_code":84,"name_similarity":85,"definition_similarity":86,"vector_similarity":87,"score":88},1870,"子宮内組織採取キット","11531000",0.146341,0.159892,0.623995,0.0272424,{"medical_device_id":90,"generic_name":91,"class_classification":58,"jmdn_code":92,"name_similarity":93,"definition_similarity":94,"vector_similarity":95,"score":96},2749,"歯科用セメントキット","70842000",0.147059,0.163399,0.623063,0.027032,{"medical_device_id":98,"generic_name":99,"class_classification":100,"jmdn_code":101,"name_similarity":102,"definition_similarity":103,"vector_similarity":104,"score":105},4168,"歯科用口腔内清掃キット","Ⅰ","70927000",0.155556,0.134375,0.620309,0.026905,{"medical_device_id":107,"generic_name":108,"class_classification":58,"jmdn_code":109,"name_similarity":110,"definition_similarity":111,"vector_similarity":112,"score":113},2772,"歯科用充填材料キット","70853002",0.166667,0.133987,0.614549,0.0268301,{"medical_device_id":115,"generic_name":116,"class_classification":58,"jmdn_code":117,"name_similarity":118,"definition_similarity":119,"vector_similarity":120,"score":121},2596,"光学的歯石歯垢検出器","33995010",0.173913,0.101754,0.609178,0.0262626,{"medical_device_id":123,"generic_name":124,"class_classification":58,"jmdn_code":125,"name_similarity":93,"definition_similarity":126,"vector_similarity":127,"score":128},2719,"歯科用インレーキット","70820000",0.164134,0.61889,0.0258592,{"medical_device_id":130,"generic_name":131,"class_classification":58,"jmdn_code":132,"name_similarity":133,"definition_similarity":134,"vector_similarity":135,"score":136},2825,"歯科用接着材料キット","70920012",0.135135,0.157738,0.62265,0.0251414,[138],{"product_code":139,"device_name":140,"device_class":8,"k510_count":141},"LFC","Device, Caries Detection",17,{"510k":143,"classification":144,"enforcement":145,"event":146,"pma":147,"warning_letter":148},"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":150,"definition_ja":151,"commentary_ja":152,"model_name":153,"source_hash":154,"reviewed_by":51,"reviewed_at":51,"created_at":155,"updated_at":155},"プラーク染め出しキット","この製品コードは、www.fda.gov\u002Fcdrh\u002Fode\u002Fconvkit.html に掲載されている1997年5月20日付ガイダンス「Convenience Kits Interim Regulatory Guidance」に従って設定されたものである。上記ガイダンスに列挙されているこの種のコンビニエンスキットは、取締裁量（enforcement discretion）の対象であり、ガイダンスに定めるすべての基準を満たす場合には、市販するにあたり市販前届出（510(k)）を必要としない。","この製品は、歯垢の染め出しに用いられる複数の物品を組み合わせたコンビニエンスキットとして分類されています。米国ではクラスIIに区分されていますが、コンビニエンスキットに関するガイダンスに基づき取締裁量の対象とされており、一定の基準を満たせば市販前届出（510(k)）による審査を経ずに市販することが認められています。","claude-sonnet-5","ab643965f3b9ed41fa5f950c13997d49a024fbf7947828ae629511a5dd468b61","2026-08-24T02:20:14.132666+00:00",{"product_code":6,"summary_ja":157,"stats":158,"stats_hash":168,"model_name":153,"created_at":169,"updated_at":169},"本製品コードでは、510(k)の累計届出件数は1件、参入企業数は1社で、直近5年間の新規届出は確認されていません（最新の判定は1978年12月）。不具合報告(MDR)は累計1件で、内訳は傷害報告が1件であり、死亡や不具合の報告は確認されていません（最新の報告月は2015年7月）。回収については、クラスI・II・IIIいずれも累計件数は0件で、回収の実績は確認されていません。",{"pma":159,"k510":160,"as_of":162,"events":163,"recalls":165,"top_problems":167},{"latest":51,"originals":50,"supplements":50},{"total":52,"last5y":50,"latest":161,"applicants":52},"1978-12-04","2026-08",{"death":50,"other":50,"total":52,"injury":52,"last5y":50,"malfunction":50,"latest_month":164},"2015-07",{"total":50,"last5y":50,"latest":51,"class_i":50,"class_ii":50,"class_iii":50,"top_root_causes":166},[],[],"c8ccc76138b8acf6f86d803e706594b7431aa86a39f205195d5d4774fa88d091","2026-08-24T05:01:48.414996+00:00",{"items":171,"total":50},[],{"items":173,"total":52},[174],{"k_number":18,"device_name":175,"applicant":176,"decision_date":161,"clearance_type":177,"decision_code":178,"statement_or_summary":51},"PLAQUE DETECTION SYSTEM","Clairol, Inc.","Traditional","SESE",{"items":180,"total":50},[]]