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EBF

Material, Tooth Shade, Resin

产品代码
EBF
器械名称
Material, Tooth Shade, Resin
管理类别
第 2 类（Class II）
21 CFR 条款
21 CFR 872.3690
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)
934 件

该代码近三年的 510(k)（51 件）

数据窗口为最近三年。最新一件：2026-07-01。

510(k) 号批准日期申请人器械名称
K2622282026-07-01Ultradent Products, Inc.Transcend Bulk Fill Flowable Composite 摘要
K2614852026-07-01Ivoclar Vivadent, Inc.Tetric plus Fill;Tetric plus Flow 摘要
K2612462026-06-18GC America, Inc.SRGC-06 摘要
K2610932026-06-02DiaDent Group InternationalDIAFIL 摘要
K2610712026-05-19DiaDent Group InternationalDIAFIL Bulk FLOW (Economic Package);DIAFIL Bulk FLOW 摘要
K2608052026-05-11Vericom Co., Ltd.Dual Core 摘要
K2613572026-04-27Voco GmbHGrandio disc multicolor 摘要
K2613562026-04-27Hangzhou SHINING3D Dental Technology CDura-Crown 摘要
K2601522026-04-23Mmtech Projetos Tecnologicos ImportacaSmart Print Bio Vitality (A2, A3, BL1, B1, A2-HT, A3 摘要
K2606612026-04-15Sprintray, Inc.Midas Restore 摘要
K2530362026-04-06Aidite (Qinhuangdao) Technology Co., LLight-curing Coloring Materials (ALCM) 摘要
K2607832026-03-11Kulzer, LLCVenus Diamond; Venus Diamond Flow; Venus Pearl; Venu 摘要
K2542452026-03-03New Stetic, SAZAFIRA® 摘要
K2601702026-01-21Hangzhou SHINING3D Dental Technology CLumiCera 摘要
K2524652025-12-05Mediclus Co., Ltd.Any-Core 摘要
K2535132025-11-07Premier Dental Products CompanyMultiMatch Flow Chameleon AntiMicrobial Composite 摘要
K2532362025-09-29Graphenano Dental S.L.G-BLOCK 摘要
K2530532025-09-23Hangzhou SHINING3D Dental Technology CDura-Crown (CB21-A1/CB21-A2/CB21-A3/CB21-B1) 摘要
K2519462025-08-29GC America, Inc.G aenial Universal Injectable II 摘要
K2512832025-06-06Mediclus Co., Ltd.Once-Fil Flow 摘要
K2503172025-05-30Spident Co., Ltd.EsFlow PLUS 摘要
K2515782025-05-27Shofu Dental CorporationBEAUTIFIL II
K2507782025-05-23Dsi Dental Solutions, Ltd.Sil-Flow 摘要
K2512392025-05-21Voco GmbHGrandioSO Unlimited
K2507632025-05-12C.E.I.B.MedReon 摘要
K2504972025-04-30Aidite (Qinhuangdao) Technology Co., LAdditive Manufacturing (Light Curing) Crown Bridge R 摘要
K2508232025-04-14Mediclus Co., Ltd.Any-Com Flow
K2502672025-03-14Kettenbach GmbH & Co. KGVisalys® Bulk Fill 1 x 4 g Syringe (15060); Visalys® 摘要
K2427132025-02-07Mediclus Co., Ltd.Any-Com Bulk 摘要
K2425722024-12-20Rizhao Huge Biomaterials Company, Ltd.TopCEM-Try in Veneer Try-in Gel 摘要
K2437202024-12-18Deltamed GmbH3Delta UNlimited
K2428162024-12-17Bisco, Inc.Quantium 摘要
K2332732024-11-27Prevest Denpro LimitedC&B Ceramic; C&B Permanent; C&B Interim 摘要
K2329942024-10-18Dentscare LtdaVittra APS Unique Flow 摘要
K2411312024-10-18Edelweiss Dentistry Products GmbHedelweiss CAD/CAM T-BLOCK; edelweiss CAD/CAM C-BLOCK 摘要
K2420972024-10-15Den-Mat Holdings, LLCDenMat Bulk Fill Composite 摘要
K2416732024-10-15Shenzhen Piocreat 3D Technology Co., LDenture Base Resin (PN-Denture (Red, White)) 摘要
K2420142024-10-08Meta Biomed Co., Ltd.Jet Flow Bulk 摘要
K2422772024-10-01Sprintray, Inc.Crown HT 摘要
K2411472024-09-26Mediclus Co., Ltd.Any-Com 摘要
K2406602024-09-17Kulzer, LLCSignum composite flow; Signum universal bond; Signum 摘要
K2325592024-09-11Arum Dentistry Co., Ltd.C&B NFH Hybrid 摘要
K2408232024-06-27Saremco Dental AGels extra low shrinkage® composite & els extra low s 摘要
K2311422024-04-25Dws S.R.L.Temporis, Irix Plus 摘要
K2401122024-03-15Sincera Technology (Changchun) Co., LtLight Cure Composite 摘要
K2406942024-03-15Ultradent Products, Inc.FORMA Composite (Shade A3D) 摘要
K2312632024-01-05Prevest Denpro LimitedFusion Core DC Flo; Fusion Flo; Fusion Flo SE; Fusio 摘要
K2330822023-12-22Rizhao Huge Biomaterials Company, Ltd.TopCEM Dual Cure Resin Cement 摘要
K2320502023-11-14Saremco Dental AGsaremco print BRIDGETEC 摘要
K2335962023-11-09Bego Bremer Goldschlägerei Wilh. HerbsVarseoSmile TriniQ 摘要
K2335022023-11-01Graphy, Inc.TERA HARZ II 摘要
FDA 官方分类页： EBF
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。