[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-NFE":3},{"classification":4,"mappedDevices":24,"similarCandidates":25,"relatedClassifications":99,"syncDates":100,"translation":107,"marketSummary":113,"recalls":126,"k510s":128,"pmas":130},{"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":19,"updated_at":20,"recall_count":21,"latest_recall_date":22,"k510_count":21,"pma_count":21,"event_count":23},6331,"NFE","Materials, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Alveolar Ridge Augmentation","2","872.3680","DE","Dental","1","",false,{"openfda":16,"definition":13,"device_name":7,"review_code":13,"device_class":8,"implant_flag":17,"product_code":6,"review_panel":10,"gmp_exempt_flag":17,"third_party_flag":17,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":13,"life_sustain_support_flag":17,"medical_specialty_description":11,"summary_malfunction_reporting":18},{},"N","Eligible","2026-08-18T05:52:53.233452+00:00","2026-08-24T02:00:49.029844+00:00",0,null,1,[],[26,34,42,49,56,63,70,78,86,93],{"medical_device_id":27,"generic_name":28,"class_classification":29,"jmdn_code":30,"name_similarity":31,"definition_similarity":21,"vector_similarity":32,"score":33},1037,"歯科用骨再建インプラント材","Ⅲ","34006009",0.162393,0.699035,0.0301178,{"medical_device_id":35,"generic_name":36,"class_classification":37,"jmdn_code":38,"name_similarity":39,"definition_similarity":21,"vector_similarity":40,"score":41},324,"吸収性歯科用骨再建インプラント材","Ⅳ","34006004",0.15748,0.707385,0.029907,{"medical_device_id":43,"generic_name":44,"class_classification":37,"jmdn_code":45,"name_similarity":46,"definition_similarity":21,"vector_similarity":47,"score":48},187,"歯科用コラーゲン使用骨再生材料","70437304",0.166667,0.660108,0.0296443,{"medical_device_id":50,"generic_name":51,"class_classification":29,"jmdn_code":52,"name_similarity":53,"definition_similarity":21,"vector_similarity":54,"score":55},483,"ポリテトラフルオロエチレン縫合糸","17467000",0.244898,0.652485,0.0293805,{"medical_device_id":57,"generic_name":58,"class_classification":29,"jmdn_code":59,"name_similarity":60,"definition_similarity":21,"vector_similarity":61,"score":62},1038,"非吸収性歯科用骨再建インプラント材","34006003",0.153846,0.682157,0.0283094,{"medical_device_id":64,"generic_name":65,"class_classification":29,"jmdn_code":66,"name_similarity":67,"definition_similarity":21,"vector_similarity":68,"score":69},617,"人工上顎骨","33168000",0.148515,0.698065,0.0275797,{"medical_device_id":71,"generic_name":72,"class_classification":73,"jmdn_code":74,"name_similarity":75,"definition_similarity":21,"vector_similarity":76,"score":77},4165,"歯科技工用セラミックス表面処理材料","Ⅰ","70918000",0.149606,0.649441,0.0250039,{"medical_device_id":79,"generic_name":80,"class_classification":81,"jmdn_code":82,"name_similarity":83,"definition_similarity":21,"vector_similarity":84,"score":85},3183,"歯科三次元積層造形用金属材料","Ⅱ","71060002",0.145038,0.648322,0.0234311,{"medical_device_id":87,"generic_name":88,"class_classification":37,"jmdn_code":89,"name_similarity":90,"definition_similarity":21,"vector_similarity":91,"score":92},260,"体内用吸収性合成・炭素繊維補綴材","33473204",0.0779221,0.702573,0.016129,{"medical_device_id":94,"generic_name":95,"class_classification":81,"jmdn_code":96,"name_similarity":97,"definition_similarity":21,"vector_similarity":98,"score":92},2687,"歯科メタルセラミック修復用金属材料","70796000",0.184874,0.600926,[],{"510k":101,"classification":102,"enforcement":103,"event":104,"pma":105,"warning_letter":106},"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":108,"definition_ja":22,"commentary_ja":109,"model_name":110,"source_hash":111,"reviewed_by":22,"reviewed_at":22,"created_at":112,"updated_at":112},"顎顔面歯槽堤増生用ポリテトラフルオロエチレン・ガラス状カーボン材料","本品は、顎顔面領域における歯槽堤増生（骨や組織のボリュームを増す処置）に用いられる、ポリテトラフルオロエチレンとガラス状カーボンを組み合わせた材料です。米国ではクラスIIに分類されており、市販前届出（510(k)）による審査を経て、既存の同等品との実質的同等性が示されることで市販が認められる規制区分に位置づけられています。","claude-sonnet-5","5dd5aeb795e13eac785b5963dc118d31b880f73258000489a1ccffbcce548992","2026-08-24T02:15:50.744711+00:00",{"product_code":6,"summary_ja":114,"stats":115,"stats_hash":124,"model_name":110,"created_at":125,"updated_at":125},"本製品コードについては、510(k)およびPMAによる承認実績は確認されていません。不具合報告（MDR）は累計1件で、内容は傷害（Injury）の報告となっています。回収の記録は確認されていません。",{"pma":116,"k510":117,"as_of":118,"events":119,"recalls":121,"top_problems":123},{"latest":22,"originals":21,"supplements":21},{"total":21,"last5y":21,"latest":22,"applicants":21},"2026-08",{"death":21,"other":21,"total":23,"injury":23,"last5y":21,"malfunction":21,"latest_month":120},"2006-08",{"total":21,"last5y":21,"latest":22,"class_i":21,"class_ii":21,"class_iii":21,"top_root_causes":122},[],[],"58804db615c92a70d0c19220c7f114e79d160309c8cbe87455d158eb8274a2a9","2026-08-24T04:57:04.90455+00:00",{"items":127,"total":21},[],{"items":129,"total":21},[],{"items":131,"total":21},[]]