台式冲牙器怎么办理FDA 注册 备案

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 rerket 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。