电动牙刷、冲牙器怎么办理FDA备案
电动牙刷、冲牙器在FDA分类目录中属于牙科手持式医疗器械，牙科手持器械是一种手持式设备，用于执行普通牙科和口腔外科中的各种任务.在FDA 分类目录中属于I类医疗械，进行备案注册便可用于海关清关和在美国市场销售。
1、FDA 注册备案流程
- 注册FDA 账号
- 申请邓BAI氏
- 申请并支付PIN
- 获取PCN
- 准备产品备案技术文件
- 申请FDA 备案
- FDA 批准，获取OWNER/OPERATORNUMBER、REGISTRATION NUMBER.
- FDA 官网展示可查,可用于清关出货和美国市场销售
2、 FDA分类目录 - 872 牙科设备 医疗器械
Subpart A - General Provisions
§ 872.1 - Scope.
§ 872.3 - Effective dates of requirementforpremarket approval.
§ 872.9 - Limitations of exemptionsfromsection 510(k) of the Federal Food, Drug, and Cosmetic Act(theact).
Subpart B - Diagnostic Devices
§ 872.1500 - Gingival fluid measurer.
§ 872.1720 - Pulp tester.
§ 872.1730 - Electrode gel forpulptesters.
§ 872.1740 - Caries detection device.
§ 872.1745 - Laser fluorescencecariesdetection device.
§ 872.1800 - Extraoral sourcex-raysystem.
§ 872.1810 - Intraoral sourcex-raysystem.
§ 872.1820 - Dental x-ray exposurealignmentdevice.
§ 872.1830 - Cephalometer.
§ 872.1840 - Dental x-ray positionindicatingdevice.
§ 872.1850 - Lead-linedpositionindicator.
§ 872.1870 - Sulfide detection device.
§ 872.1905 - Dental x-ray film holder.
§ 872.2050 - Dental sonography device.
§ 872.2060 - Jaw tracking device.
Subpart C [Reserved]
Subpart D - Prosthetic Devices
§ 872.3060 - Noble metal alloy.
§ 872.3070 - Dental amalgam, mercury,andamalgam alloy.
§ 872.3080 - Mercury and alloydispenser.
§ 872.3100 - Dental amalgamator.
§ 872.3110 - Dental amalgam capsule.
§ 872.3130 - Preformed anchor.
§ 872.3140 - Resin applicator.
§ 872.3150 - Articulator.
§ 872.3165 - Precision attachment.
§ 872.3200 - Resin tooth bonding agent.
§ 872.3220 - Facebow.
§ 872.3240 - Dental bur.
§ 872.3250 - Calcium hydroxidecavityliner.
§ 872.3260 - Cavity varnish.
§ 872.3275 - Dental cement.
§ 872.3285 - Preformed clasp.
§ 872.3300 - Hydrophilic resin coatingfordentures.
§ 872.3310 - Coating material forresinfillings.
§ 872.3330 - Preformed crown.
§ 872.3350 - Gold or stainlesssteelcusp.
§ 872.3360 - Preformed cusp.
§ 872.3400 - Karaya and sodium borate withorwithout acacia denture adhesive.
§ 872.3410 - Ethylene oxidehomopolymerand/or carboxymethylcellulose sodium dentureadhesive.
§ 872.3420 - Carboxymethylcellulosesodiumand cationic polyacrylamide polymer denture adhesive.
§ 872.3450 - Ethylene oxidehomopolymerand/or karaya denture adhesive.
§ 872.3480 - Polyacrylamide polymer(modifiedcationic) denture adhesive.
§ 872.3490 - Carboxymethylcellulosesodiumand/or polyvinylmethylether maleic acid calcium-sodium doublesaltdenture adhesive.
§ 872.3500 - Polyvinylmethylethermaleicanhydride (PVM-MA), acid copolymer, andcarboxymethylcellulosesodium (NACMC) denture adhesive.
§ 872.3520 - OTC denture cleanser.
§ 872.3530 - Mechanical denture cleaner.
§ 872.3540 - OTC denture cushion or pad.
§ 872.3560 - OTC denture reliner.
§ 872.3570 - OTC denture repair kit.
§ 872.3580 - Preformed golddenturetooth.
§ 872.3590 - Preformed plasticdenturetooth.
§ 872.3600 - Partially fabricateddenturekit.
§ 872.3630 - Endosseous dentalimplantabutment.
§ 872.3640 - Endosseous dental implant.
§ 872.3645 - Subperiostealimplantmaterial.
§ 872.3660 - Impression material.
§ 872.3661 - Optical Impression SystemsforCAD/CAM.
§ 872.3670 - Resin impressiontraymaterial.
§ 872.3680 - Polytetrafluoroethylene(PTFE)vitreous carbon materials.
§ 872.3690 - Tooth shade resin material.
§ 872.3710 - Base metal alloy.
§ 872.3730 - Pantograph.
§ 872.3740 - Retentive and splintingpin.
§ 872.3750 - Bracket adhesive resin andtoothconditioner.
§ 872.3760 - Denture relining, repairing,orrebasing resin.
§ 872.3765 - Pit and fissure sealantandconditioner.
§ 872.3770 - Temporary crown andbridgeresin.
§ 872.3810 - Root canal post.
§ 872.3820 - Root canal filling resin.
§ 872.3830 - Endodontic paper point.
§ 872.3840 - Endodontic silver point.
§ 872.3850 - Gutta percha.
§ 872.3890 - Endodonticstabilizingsplint.
§ 872.3900 - Posterior artificial toothwitha metal insert.
§ 872.3910 - Backing and facing foranartificial tooth.
§ 872.3920 - Porcelain tooth.
§ 872.3930 - Bone grafting material.
§ 872.3940 - Total temporomandibularjointprosthesis.
§ 872.3950 - Glenoid fossa prosthesis.
§ 872.3960 - Mandibularcondyleprosthesis.
§ 872.3970 - Interarticular discprosthesis(interpositional implant).
§ 872.3980 - Endosseous dentalimplantaccessories.
Subpart E - Surgical Devices
§ 872.4120 - Bone cutting instrumentandaccessories.
§ 872.4130 - Intraoral dental drill.
§ 872.4200 - Dental handpieceandaccessories.
§ 872.4465 - Gas-powered jet injector.
§ 872.4475 - Spring-powered jetinjector.
§ 872.4535 - Dental diamond instrument.
§ 872.4565 - Dental hand instrument.
§ 872.4600 - Intraoral ligature andwirelock.
§ 872.4620 - Fiber optic dental light.
§ 872.4630 - Dental operating light.
§ 872.4730 - Dental injecting needle.
§ 872.4760 - Bone plate.
§ 872.4770 - Temporary mandibularcondylereconstruction plate.
§ 872.4840 - Rotary scaler.
§ 872.4850 - Ultrasonic scaler.
§ 872.4880 - Intraosseous fixation screworwire.
§ 872.4920 - Dental electrosurgical unitandaccessories.
Subpart F - Therapeutic Devices
§ 872.5410 - Orthodontic applianceandaccessories.
§ 872.5470 - Orthodontic plasticbracket.
§ 872.5500 - Extraoralorthodonticheadgear.
§ 872.5525 - Preformed tooth positioner.
§ 872.5550 - Teething ring.
§ 872.5560 - Electrical salivarystimulatorysystem.
§ 872.5570 - Intraoral devices forsnoringand intraoral devices for snoring and obstructive sleepapnea.
§ 872.5571 - Auto titration device fororalappliances.
§ 872.5580 - Oral rinse to reducetheadhesion of dental plaque.
Subpart G - Miscellaneous Devices
§ 872.6010 - Abrasive deviceandaccessories.
§ 872.6030 - Oral cavity abrasivepolishingagent.
§ 872.6050 - Saliva absorber.
§ 872.6070 - Ultraviolet activatorforpolymerization.
§ 872.6080 - Airbrush.
§ 872.6100 - Anesthetic warmer.
§ 872.6140 - Articulation paper.
§ 872.6200 - Base plate shellac.
§ 872.6250 - Dental chairandaccessories.
§ 872.6290 - Prophylaxis cup.
§ 872.6300 - Rubber dam and accessories.
§ 872.6350 - Ultraviolet detector.
§ 872.6390 - Dental floss.
§ 872.6475 - Heat source forbleachingteeth.
§ 872.6510 - Oral irrigation unit.
§ 872.6570 - Impression tube.
§ 872.6640 - Dental operative unitandaccessories.
§ 872.6650 - Massaging pick or tip fororalhygiene.
§ 872.6660 - Porcelain powder forclinicaluse.
§ 872.6670 - Silicate protector.
§ 872.6710 - Boiling water sterilizer.
§ 872.6730 - Endodontic dryheatsterilizer.
§ 872.6770 - Cartridge syringe.
§ 872.6855 - Manual toothbrush.
§ 872.6865 - Powered toothbrush.
§ 872.6870 - Disposable fluoride tray.
§ 872.6880 - Preformed impression tray.
§ 872.6890 - Intraoral dental wax.
3、牙科手持医疗器械产品目录
主要包括电动牙刷，冲牙器,牙周病或牙髓冲洗注射器、牙髓刮除器、手术刮除器、牙周刮除器、手术刮刮器、牙科手术升降机、手术牙科挖掘机、手术探查器手术骨锉、牙周锉、牙周探针、手术钳、手术拔牙钳、手术止血钳、牙周锄头， 手术基质轮廓仪， 手术切割仪， 手术切缘整理牙周刀， 牙周标记器， 手术钳， 牙髓根管堵塞器， 牙髓根管制备器，手术活检打孔器， 牙髓管铰刀， 牙冠去除器， 牙周刮牙机， 手术截骨刀， 牙髓拉刀， 牙结石去除器械， 牙科深度计仪，塑料牙科填充器械， 牙科器械手柄， 手术组织剪刀， 口腔镜， 正畸带驱动器， 正畸带推杆， 正畸带安装器， 正畸托槽矫正器， 正畸钳，正畸结扎器， 镊子， 关节纸， 牙科敷料钳， 牙科基质带， 基质固定器， 牙科牵开器， 牙科牵开器配件等等。
