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Any device that exceeds the limitations found in 21 CFR sections 862.9 to 892.9 or identified in the Federal Register  (82 FR 31976) available at https:\u002F\u002Fwww.federalregister.gov\u002Fdocuments\u002F2017\u002F07\u002F11\u002F2017-14453\u002Fmedical-devices-exemptions-from-premarket-notification-class-ii-devices is required to submit a premarket notification submission (510(k)) to FDA before introducing a device into interstate commerce.  If a manufacturer’s device is exempt from the premarket notification requirement, then a premarket notification submission and FDA clearance is not required before marketing the device in the U.S. however, manufacturers are required to meet all other requirements under the Federal Food Drug & Cosmetic and implementing regulations including (but not limited to) registration and listing requirements. Please see the Device Registration and Listing website for additional information on registration and listing.    This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at https:\u002F\u002Fwww.fda.gov\u002Fdownloads\u002FMedicalDevices\u002FDeviceRegulationandGuidance\u002FGuidanceDocuments\u002Fucm080217.pdf.  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":22,"device_class":8,"implant_flag":23,"product_code":6,"review_panel":10,"gmp_exempt_flag":23,"third_party_flag":23,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":22,"life_sustain_support_flag":23,"medical_specialty_description":11,"summary_malfunction_reporting":24},{"fei_number":17,"registration_number":20},[18,19],"3001708019","3043303267",[21,19],"2031508","","N","Eligible","2026-08-18T05:52:50.495594+00:00",0,null,[],[30,39,48,55,63,70,78,86,93,102],{"medical_device_id":31,"generic_name":32,"class_classification":33,"jmdn_code":34,"name_similarity":35,"definition_similarity":36,"vector_similarity":37,"score":38},3294,"歯科用デジタル式X線センサ","Ⅰ","70040009",0.305556,0.158598,0.572471,0.02886,{"medical_device_id":40,"generic_name":41,"class_classification":42,"jmdn_code":43,"name_similarity":44,"definition_similarity":45,"vector_similarity":46,"score":47},2625,"可搬式歯科用オプション追加型ユニット","Ⅱ","70726000",0.132075,0.146538,0.604427,0.0163934,{"medical_device_id":49,"generic_name":50,"class_classification":33,"jmdn_code":51,"name_similarity":52,"definition_similarity":53,"vector_similarity":54,"score":47},4017,"歯科印象採得用トレー","16350000",0.363636,0.0935252,0.497159,{"medical_device_id":56,"generic_name":57,"class_classification":33,"jmdn_code":58,"name_similarity":59,"definition_similarity":60,"vector_similarity":61,"score":62},3276,"X線被曝低減装置","70037000",0.12766,0.128028,0.597126,0.016129,{"medical_device_id":64,"generic_name":65,"class_classification":33,"jmdn_code":66,"name_similarity":67,"definition_similarity":68,"vector_similarity":69,"score":62},4110,"歯科印象トレー用レジン","70832000",0.351351,0.101754,0.483717,{"medical_device_id":71,"generic_name":72,"class_classification":42,"jmdn_code":73,"name_similarity":74,"definition_similarity":75,"vector_similarity":76,"score":77},2620,"歯科用オプション追加型ユニット","34991020",0.159091,0.146774,0.595122,0.015873,{"medical_device_id":79,"generic_name":80,"class_classification":42,"jmdn_code":81,"name_similarity":82,"definition_similarity":83,"vector_similarity":84,"score":85},2834,"歯科用長期的使用金属鉤成形品","70932000",0.145455,0.0905861,0.590581,0.015625,{"medical_device_id":87,"generic_name":88,"class_classification":33,"jmdn_code":89,"name_similarity":90,"definition_similarity":91,"vector_similarity":92,"score":85},4027,"歯科用ファイルラスプ","31878011",0.3,0.114983,0.510625,{"medical_device_id":94,"generic_name":95,"class_classification":96,"jmdn_code":97,"name_similarity":98,"definition_similarity":99,"vector_similarity":100,"score":101},1051,"医薬品含有歯科用接着材料キット","Ⅲ","70920003",0.122807,0.138354,0.585976,0.0153846,{"medical_device_id":103,"generic_name":104,"class_classification":33,"jmdn_code":105,"name_similarity":90,"definition_similarity":106,"vector_similarity":107,"score":101},4274,"歯科用開創器","13380000",0.0874786,0.502642,[109,113,117,121,124,127],{"product_code":110,"device_name":111,"device_class":8,"k510_count":112},"OWB","Interventional Fluoroscopic X-Ray System",323,{"product_code":114,"device_name":115,"device_class":8,"k510_count":116},"JAA","System, X-Ray, Fluoroscopic, Image-Intensified",300,{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"OXO","Image-Intensified Fluoroscopic X-Ray System, Mobile",82,{"product_code":122,"device_name":123,"device_class":8,"k510_count":26},"OII","Arthrogram Tray",{"product_code":125,"device_name":126,"device_class":8,"k510_count":26},"QHY","Solid State Fluoroscopic X-Ray Imager",{"product_code":128,"device_name":129,"device_class":8,"k510_count":26},"RCC","C-Arm Fluoroscopic X-Ray System",{"510k":131,"classification":132,"enforcement":133,"event":134,"pma":135,"warning_letter":136},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:58:35.995+00:00","2026-08-18T06:36:30.549+00:00","2026-08-19T04:07:02.603+00:00"]