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/OPERATOR NUMBER、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 requirement forpremarket approval.
   § 872.9 - Limitations of exemptions fromsection 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 for pulptesters.
   § 872.1740 - Caries detection device.
   § 872.1745 - Laser fluorescence cariesdetection device.
   § 872.1800 - Extraoral source x-raysystem.
   § 872.1810 - Intraoral source x-raysystem.
   § 872.1820 - Dental x-ray exposure alignmentdevice.
   § 872.1830 - Cephalometer.
   § 872.1840 - Dental x-ray positionindicating device.
   § 872.1850 - Lead-lined positionindicator.
   § 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 hydroxide cavityliner.
   § 872.3260 - Cavity varnish.
   § 872.3275 - Dental cement.
   § 872.3285 - Preformed clasp.
   § 872.3300 - Hydrophilic resin coating fordentures.
   § 872.3310 - Coating material for resinfillings.
   § 872.3330 - Preformed crown.
   § 872.3350 - Gold or stainless steelcusp.
   § 872.3360 - Preformed cusp.
   § 872.3400 - Karaya and sodium borate withor without acacia denture adhesive.
   § 872.3410 - Ethylene oxide homopolymerand/or carboxymethylcellulose sodium denture adhesive.
   § 872.3420 - Carboxymethylcellulose sodiumand cationic polyacrylamide polymer denture adhesive.
   § 872.3450 - Ethylene oxide homopolymerand/or karaya denture adhesive.
   § 872.3480 - Polyacrylamide polymer(modified cationic) denture adhesive.
   § 872.3490 - Carboxymethylcellulose sodiumand/or polyvinylmethylether maleic acid calcium-sodium double saltdenture adhesive.
   § 872.3500 - Polyvinylmethylether maleicanhydride (PVM-MA), acid copolymer, and carboxymethylcellulosesodium (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 gold denturetooth.
   § 872.3590 - Preformed plastic denturetooth.
   § 872.3600 - Partially fabricated denturekit.
   § 872.3630 - Endosseous dental implantabutment.
   § 872.3640 - Endosseous dental implant.
   § 872.3645 - Subperiosteal implantmaterial.
   § 872.3660 - Impression material.
   § 872.3661 - Optical Impression Systems forCAD/CAM.
   § 872.3670 - Resin impression traymaterial.
   § 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 andtooth conditioner.
   § 872.3760 - Denture relining, repairing, orrebasing resin.
   § 872.3765 - Pit and fissure sealant andconditioner.
   § 872.3770 - Temporary crown and bridgeresin.
   § 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 - Endodontic stabilizingsplint.
   § 872.3900 - Posterior artificial tooth witha metal insert.
   § 872.3910 - Backing and facing for anartificial tooth.
   § 872.3920 - Porcelain tooth.
   § 872.3930 - Bone grafting material.
   § 872.3940 - Total temporomandibular jointprosthesis.
   § 872.3950 - Glenoid fossa prosthesis.
   § 872.3960 - Mandibular condyleprosthesis.
   § 872.3970 - Interarticular disc prosthesis(interpositional implant).
   § 872.3980 - Endosseous dental implantaccessories.

Subpart E - Surgical Devices
   § 872.4120 - Bone cutting instrument andaccessories.
   § 872.4130 - Intraoral dental drill.
   § 872.4200 - Dental handpiece andaccessories.
   § 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 and wirelock.
   § 872.4620 - Fiber optic dental light.
   § 872.4630 - Dental operating light.
   § 872.4730 - Dental injecting needle.
   § 872.4760 - Bone plate.
   § 872.4770 - Temporary mandibular condylereconstruction plate.
   § 872.4840 - Rotary scaler.
   § 872.4850 - Ultrasonic scaler.
   § 872.4880 - Intraosseous fixation screw orwire.
   § 872.4920 - Dental electrosurgical unit andaccessories.

Subpart F - Therapeutic Devices
   § 872.5410 - Orthodontic appliance andaccessories.
   § 872.5470 - Orthodontic plasticbracket.
   § 872.5500 - Extraoral orthodonticheadgear.
   § 872.5525 - Preformed tooth positioner.
   § 872.5550 - Teething ring.
   § 872.5560 - Electrical salivary stimulatorysystem.
   § 872.5570 - Intraoral devices for snoringand intraoral devices for snoring and obstructive sleep apnea.
   § 872.5571 - Auto titration device for oralappliances.
   § 872.5580 - Oral rinse to reduce theadhesion of dental plaque.

Subpart G - Miscellaneous Devices
   § 872.6010 - Abrasive device andaccessories.
   § 872.6030 - Oral cavity abrasive polishingagent.
   § 872.6050 - Saliva absorber.
   § 872.6070 - Ultraviolet activator forpolymerization.
   § 872.6080 - Airbrush.
   § 872.6100 - Anesthetic warmer.
   § 872.6140 - Articulation paper.
   § 872.6200 - Base plate shellac.
   § 872.6250 - Dental chair andaccessories.
   § 872.6290 - Prophylaxis cup.
   § 872.6300 - Rubber dam and accessories.
   § 872.6350 - Ultraviolet detector.
   § 872.6390 - Dental floss.
   § 872.6475 - Heat source for bleachingteeth.
   § 872.6510 - Oral irrigation unit.
   § 872.6570 - Impression tube.
   § 872.6640 - Dental operative unit andaccessories.
   § 872.6650 - Massaging pick or tip for oralhygiene.
   § 872.6660 - Porcelain powder for clinicaluse.
   § 872.6670 - Silicate protector.
   § 872.6710 - Boiling water sterilizer.
   § 872.6730 - Endodontic dry heatsterilizer.
   § 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。