NXC

Aligner, Sequential

产品代码
NXC
器械名称
Aligner, Sequential
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 872.5470
FDA 专业组
Dental
上市路径
需提交 510(k) 上市前通告
标记
可走第三方审查
该代码近三年的 510(k)
34 件
其中 Summary 已存档
27 份,可直接下载
FDA 历史累计 510(k)
145 件(全部年份;本站只收录近三年的明细)

FDA 分类定义

The device moves the teeth by continuous gentle force for treatment of minor tooth malocclusion.

定义原文来自 FDA 器械分类库,属美国联邦政府作品(公有领域)。

该代码近三年的 510(k)(34 件)

数据窗口为最近三年。最新一件:2026-07-02。

510(k) 号批准日期申请人器械名称摘要
K2605272026-07-02Avinent Implant System S.L.U.FACE4D AlignerFDA
K2607882026-05-08Smylio, Inc.Smylio Aligners
K2607222026-04-15Dentsply Sirona, Inc.SureSmile Aligner (ASSY500020)PDF
K2532822026-02-03Dror Orthodesign , Ltd.ZSmile SystemPDF
K2514542026-01-07Beame Medical Technology (Shenzhen) LiClear Aligner (SCF-3348)PDF
K2507392025-11-07Dreve Dentamid GmbHPrimeprint Direct AlignerPDF
K2529312025-10-23Align Technology, Inc.Invisalign® Palatal Expander SystemPDF
K2528702025-10-09Align Technology, Inc.Invisalign Specifix Attachment SystemPDF
K2517582025-09-11Tns Co., Ltd.Serafin®PDF
K2523802025-08-29Align Technology, Inc.Invisalign SystemPDF
K2514152025-08-27Aidite (Qinhuangdao) Technology Co., LAdditively Manufactured Aligner ResinPDF
K2516162025-07-22Ods Co., Ltd.Clear MiracleFDA
K2426372025-05-21Mem Dental Technology Co., Ltd.MEM Clear Aligner SystemPDF
K2503432025-04-08LuxCreo, Inc.LuxCreo Clear Aligner SystemPDF
K2504872025-02-20Ormco CorporationSparkTM Clear Aligner SystemPDF
K2427152025-01-16Pearl Digital, Inc.Pearl Clear AlignerFDA
K2429292024-12-20Xplora 3D Europe S.LFas Aligner SystemPDF
K2428922024-12-19Cristaline Aligners GmbHCristaline Aligners Z FLXPDF
K2331522024-12-12Geniova Technologies Sociedad LimitadaGENIOVA alignersFDA
K2405012024-10-11Ormco CorporationSpark™ Clear Aligner SystemPDF
K2333562024-08-08Laxmi Dental Export Pvt., Ltd.Illusion Aligner Pro: Illusion Aligner FLXPDF
K2411372024-08-01Clear Moves AlignersClear Moves AlignerPDF
K2411872024-07-26Alien Milling TechnologiesAlien AlignersFDA
K2414122024-06-18Align Technology, Inc.Invisalign SystemPDF
K2339352024-04-05Park Dental Research CorporationDigiLine Direct Print Aligner SystemPDF
K2400382024-04-04Space Maintainers Laboratories (Sml)Clear Moves AlignersPDF
K2326532024-04-03Blue Sky Bio, LLCBlue Sky Plan Software, Blue Sky Bio Aligner Z, and PDF
K2405972024-03-05Graphy, Inc.TERA HARZ CLEARFDA
K2335442024-02-22Dentis Co., Ltd.MESHEETPDF
K2320742024-02-22Tns Co., Ltd.Serafin®PDF
K2328872023-12-15Align Technology, Inc.Invisalign Palatal Expander SystemPDF
K2301992023-10-18Dentsply Sirona, Inc.Byte Aligner SystemPDF
K2332572023-09-293M Company, Unitek Orthodontic Product3M™ Clarity™Aligners with Quick AttachmentsPDF
K2322332023-09-26Align Technology, Inc.Invisalign System with Mandibular Advancement FeaturPDF

其中 27 件的 Summary 已存档在本站,点 PDF 直接下载;其余给 FDA 官方链接。

FDA 官方分类页: NXC
分类与上市路径以 FDA 现行公告为准。本页数据来自 openFDA(CC0 公有领域),不构成注册策略建议。