[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"fda-device-PWL":3},{"classification":4,"mappedDevices":50,"similarCandidates":51,"relatedClassifications":52,"syncDates":261},{"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":45,"updated_at":46,"recall_count":47,"latest_recall_date":48,"k510_count":49,"pma_count":49,"event_count":49},2257,"PWL","Oral Surgery Tray","1","872.4565","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 http:\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":42,"device_class":8,"implant_flag":43,"product_code":6,"review_panel":10,"gmp_exempt_flag":43,"third_party_flag":43,"medical_specialty":10,"regulation_number":9,"submission_type_id":12,"unclassified_reason":42,"life_sustain_support_flag":43,"medical_specialty_description":11,"summary_malfunction_reporting":44},{"fei_number":17,"registration_number":38},[18,19,20,21,22,23,24,25,26,27,28,29,30,31,32,33,34,35,36,37],"3005587147","3044150131","3007329020","3009888344","3014257280","3031886796","3004111573","1643817","3026197444","3018077422","3010442693","3031582434","1000512168","3001236905","3003394081","1051594","3010155661","3002902735","3006410968","3009203853",[18,19,20,21,22,23,24,39,25,26,27,40,28,29,41,32,33,34,36,37],"1423537","1061124","9616088","","N","Ineligible","2026-08-18T05:52:49.993647+00:00","2026-08-18T22:05:38.961415+00:00",15,"2022-12-21",0,[],[],[53,57,61,65,69,72,76,80,83,87,91,95,98,101,104,108,111,114,117,121,124,127,131,134,137,140,144,147,150,153,156,160,163,166,169,172,175,179,182,185,188,191,194,197,200,203,206,209,213,216,219,222,225,228,231,234,237,240,243,246,249,252,255,258],{"product_code":54,"device_name":55,"device_class":8,"k510_count":56},"EKJ","Burnisher, Operative",72,{"product_code":58,"device_name":59,"device_class":8,"k510_count":60},"EKS","File, Pulp Canal, Endodontic",31,{"product_code":62,"device_name":63,"device_class":8,"k510_count":64},"EIS","Remover, Crown",19,{"product_code":66,"device_name":67,"device_class":8,"k510_count":68},"DZN","Instruments, Dental Hand",16,{"product_code":70,"device_name":71,"device_class":8,"k510_count":68},"EIC","Syringe, Periodontic, Endodontic, Irrigating",{"product_code":73,"device_name":74,"device_class":8,"k510_count":75},"EID","Syringe, Restorative And Impression Material",13,{"product_code":77,"device_name":78,"device_class":8,"k510_count":79},"EAX","Mirror, Mouth",12,{"product_code":81,"device_name":82,"device_class":8,"k510_count":79},"ECB","Unit, Syringe, Air And\u002FOr Water",{"product_code":84,"device_name":85,"device_class":8,"k510_count":86},"EMG","Forceps, Tooth Extractor, Surgical",10,{"product_code":88,"device_name":89,"device_class":8,"k510_count":90},"EIX","Probe, Periodontic",9,{"product_code":92,"device_name":93,"device_class":8,"k510_count":94},"EIG","Retractor, All Types",8,{"product_code":96,"device_name":97,"device_class":8,"k510_count":94},"EIL","Gauge, Depth, Instrument, Dental",{"product_code":99,"device_name":100,"device_class":8,"k510_count":94},"EJB","Handle, Instrument, Dental",{"product_code":102,"device_name":103,"device_class":8,"k510_count":94},"EMH","Forceps, Rongeur, Surgical",{"product_code":105,"device_name":106,"device_class":8,"k510_count":107},"EGN","Scissors, Surgical Tissue, Dental",7,{"product_code":109,"device_name":110,"device_class":8,"k510_count":107},"EKW","Broach, Endodontic",{"product_code":112,"device_name":113,"device_class":8,"k510_count":107},"EMS","Curette, Periodontic",{"product_code":115,"device_name":116,"device_class":8,"k510_count":107},"JEX","Plier, Orthodontic",{"product_code":118,"device_name":119,"device_class":8,"k510_count":120},"EKP","Reamer, Pulp Canal, Endodontic",6,{"product_code":122,"device_name":123,"device_class":8,"k510_count":120},"EKR","Plugger, Root Canal, Endodontic",{"product_code":125,"device_name":126,"device_class":8,"k510_count":120},"EMJ","Elevator, Surgical, Dental",{"product_code":128,"device_name":129,"device_class":8,"k510_count":130},"EFL","Forceps, Dressing, Dental",5,{"product_code":132,"device_name":133,"device_class":8,"k510_count":130},"EIK","Carver, Wax, Dental",{"product_code":135,"device_name":136,"device_class":8,"k510_count":130},"EIY","Instrument, Filling, Plastic, Dental",{"product_code":138,"device_name":139,"device_class":8,"k510_count":130},"EMN","Scaler, Periodontic",{"product_code":141,"device_name":142,"device_class":8,"k510_count":143},"EIB","Syringe, Irrigating (Dental)",4,{"product_code":145,"device_name":146,"device_class":8,"k510_count":143},"EIF","Accessories, Retractor, Dental",{"product_code":148,"device_name":149,"device_class":8,"k510_count":143},"ELA","Instrument, Hand, Calculus Removal",{"product_code":151,"device_name":152,"device_class":8,"k510_count":143},"EMI","File, Bone, Surgical",{"product_code":154,"device_name":155,"device_class":8,"k510_count":143},"EMM","Chisel, Osteotome, Surgical",{"product_code":157,"device_name":158,"device_class":8,"k510_count":159},"ECR","Setter, Band, Orthodontic",3,{"product_code":161,"device_name":162,"device_class":8,"k510_count":159},"EKB","Explorer, Operative",{"product_code":164,"device_name":165,"device_class":8,"k510_count":159},"EKG","Condenser, Amalgam And Foil, Operative",{"product_code":167,"device_name":168,"device_class":8,"k510_count":159},"EKH","Carver, Dental Amalgam, Operative",{"product_code":170,"device_name":171,"device_class":8,"k510_count":159},"EME","Punch, Biopsy, Surgical",{"product_code":173,"device_name":174,"device_class":8,"k510_count":159},"JEP","Retainer, Matrix",{"product_code":176,"device_name":177,"device_class":8,"k510_count":178},"ECQ","Aligner, Bracket, Orthodontic",2,{"product_code":180,"device_name":181,"device_class":8,"k510_count":178},"ECS","Pusher, Band, Orthodontic",{"product_code":183,"device_name":184,"device_class":8,"k510_count":178},"EJY","Pliers, Operative",{"product_code":186,"device_name":187,"device_class":8,"k510_count":178},"EJZ","Knife, Margin Finishing, Operative",{"product_code":189,"device_name":190,"device_class":8,"k510_count":178},"EKA","File, Margin Finishing, Operative",{"product_code":192,"device_name":193,"device_class":8,"k510_count":178},"EKC","Excavator, Dental, Operative",{"product_code":195,"device_name":196,"device_class":8,"k510_count":178},"EKD","Instrument, Cutting, Operative",{"product_code":198,"device_name":199,"device_class":8,"k510_count":178},"EKI","Carrier, Amalgam, Operative",{"product_code":201,"device_name":202,"device_class":8,"k510_count":178},"EKQ","Preparer, Root Canal Endodontic",{"product_code":204,"device_name":205,"device_class":8,"k510_count":178},"EMD","Hemostat, Surgical",{"product_code":207,"device_name":208,"device_class":8,"k510_count":178},"EML","Chisel, Bone, Surgical",{"product_code":210,"device_name":211,"device_class":8,"k510_count":212},"EGI","Parallelometer",1,{"product_code":214,"device_name":215,"device_class":8,"k510_count":212},"EIR","Scissors, Collar And Crown",{"product_code":217,"device_name":218,"device_class":8,"k510_count":212},"EKK","Spreader, Pulp Canal Filling Material, Endodontic",{"product_code":220,"device_name":221,"device_class":8,"k510_count":212},"EMK","Curette, Surgical, Dental",{"product_code":223,"device_name":224,"device_class":8,"k510_count":212},"EMR","File, Periodontic",{"product_code":226,"device_name":227,"device_class":8,"k510_count":49},"ECP","Instrument, Ligature Tucking, Orthodontic",{"product_code":229,"device_name":230,"device_class":8,"k510_count":49},"ECT","Driver, Band, Orthodontic",{"product_code":232,"device_name":233,"device_class":8,"k510_count":49},"EFK","Forceps, Articulation Paper",{"product_code":235,"device_name":236,"device_class":8,"k510_count":49},"EKE","Curette, Operative",{"product_code":238,"device_name":239,"device_class":8,"k510_count":49},"EKF","Instrument, Contouring, Matrix, Operative",{"product_code":241,"device_name":242,"device_class":8,"k510_count":49},"EKT","Curette, Endodontic",{"product_code":244,"device_name":245,"device_class":8,"k510_count":49},"EMO","Knife, Periodontic",{"product_code":247,"device_name":248,"device_class":8,"k510_count":49},"EMP","Marker, Periodontic",{"product_code":250,"device_name":251,"device_class":8,"k510_count":49},"EMQ","Hoe, Periodontic",{"product_code":253,"device_name":254,"device_class":8,"k510_count":49},"NYC","Dental Prophylaxis Kit",{"product_code":256,"device_name":257,"device_class":8,"k510_count":49},"NYF","Gingival Retraction Kit",{"product_code":259,"device_name":260,"device_class":8,"k510_count":49},"NYG","Lapping Tool Kit",{"510k":262,"classification":263,"enforcement":264,"event":265,"pma":266,"warning_letter":267},"2026-08-18T06:35:18.347+00:00","2026-08-18T05:52:53.75+00:00","2026-08-18T08:01:54.918+00:00","2026-08-19T02:37:02.918+00:00","2026-08-18T06:36:30.549+00:00","2026-08-18T06:42:29.411+00:00"]