EBI

Resin, Denture, Relining, Repairing, Rebasing

产品代码
EBI
器械名称
Resin, Denture, Relining, Repairing, Rebasing
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 872.3760
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)
30 件
其中 Summary 已存档
28 份,可直接下载
FDA 历史累计 510(k)
335 件(全部年份;本站只收录近三年的明细)

该代码近三年的 510(k)(30 件)

数据窗口为最近三年。最新一件:2026-08-27。

510(k) 号批准日期申请人器械名称摘要
K2618022026-08-27Prismatik Dentalcraft, Inc.Glidewell™ Denture Base ResinPDF
K2616262026-08-13Guangzhou Heygears IMC., Inc.UltraPrint Flexible Denture UVPDF
K2626812026-07-313BFAB TEKNOLOJI A.S.NanoCeram ResinPDF
K2623002026-07-08Formlabs Ohio, Inc.Denture Base Resin V2PDF
K2614742026-07-01Dentca, Inc.DENTCA Tru FlexiblePDF
K2605692026-06-02Carbon, Inc.DB 4000 High Impact Denture BasePDF
K2603762026-05-06Shandong Huge Dental Material CorporatDenture BasePDF
K2533652025-11-25LuxCreo, Inc.LuxCreo Flexible Partial Denture ResinPDF
K2536812025-11-21Graphy, Inc.TERA HARZ Hard Denture (THD-C-500); TERA HARZ Hard DPDF
K2533242025-11-20Guangzhou Heygears IMC., Inc.UltraPrint-Dental Denture UVPDF
K2524302025-10-30Detax GmbHFreeprint® denture flexFDA
K2520352025-09-17Kamemizu Chemical Industry Co., Ltd.DENTURE SOFT EX (Pink set); DENTURE SOFT EX (White sPDF
K2503022025-06-25Prismatik Dentalcraft, Inc.Flexible Partial ResinPDF
K2428972025-06-03Clemde SA DE CVPartial FlexPDF
K2504892025-05-20Keystone IndustriesFP3DPDF
K2506172025-04-29Sprintray, Inc.Apex FlexPDF
K2433562025-04-11Asiga Pty, Ltd.Asiga DentaBASEPDF
K2509462025-03-31Hangzhou SHINING3D Dental Technology CDenture Base Resin DT20PDF
K2431032024-12-23Riton 3D Technology Co., Ltd.Denture BasePDF
K2433362024-12-17Dentsply Sirona, Inc.Lucitone Digital Print Denture™ SystemPDF
K2428842024-11-22Aidite (Qinhuangdao) Technology Co., LAdditively Manufactured Denture ResinPDF
K2410892024-10-24Keystone IndustriesKeyPrint KeyDenture BaseFDA
K2414932024-09-12Prismatik Dentalcraft, Inc.Glidewell™ 3DP Denture Base ResinPDF
K2410712024-09-04Vertex-Dental B.V.NextDent Jet Denture Base; NextDent Jet Denture TeetPDF
K2406882024-06-20Belport Company, Inc., Gingi-PakRODIN Titan 3D ResinPDF
K2338592024-03-05YAMAHACHI DENTAL MFG., Co.BASIS FLOW IIPDF
K2339952024-02-23Ivoclar Vivadent, Inc.Ivotion Base PrintPDF
K2331712023-11-27Clemde SA DE CVPF Keep; Cad Cam Keep BlockPDF
K2313882023-10-20Vertex-Dental B.V.NextDent BasePDF
K2315782023-10-20Dentsply SironaLucitone Digital Print Denture SystemPDF

其中 28 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: EBI
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。