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EIH

Powder, Porcelain

产品代码
EIH
器械名称
Powder, Porcelain
管理类别
第 2 类(Class II)
21 CFR 条款
21 CFR 872.6660
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)
55 件
其中 Summary 已存档
47 份,可直接下载
FDA 历史累计 510(k)
487 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)(55 件)

数据窗口为最近三年。最新一件:2026-08-21。

510(k) 号批准日期申请人器械名称摘要
K2620742026-08-21Mediclus Co., Ltd.Any-ZircosPDF
K2622392026-07-30Prismatik Dentalcraft, Inc.Obsidian® Press Over ZirconiaPDF
K2610462026-07-17Hunan Qinghao Puzhong Technology Co., …Dental Zirconia Blank & Coloring LiquidPDF
K2621952026-06-30Zima International Inc., dba DandyDandy Ceramic Stain and GlazePDF
K2609182026-06-29Amann Girrbach AGZolid LunarisPDF
K2608592026-06-11Hass Corp.Rosetta SM, Rosetta SPPDF
K2531912026-05-21Dental Creativ Management GmbHDCMhotbond zirconPDF
K2600672026-04-09Shandong Huge Dental Material Corporat…Eternal Art Porcelain PowdersPDF
K2603702026-03-30Bloomden Bioceramics (HuNan) Co., Ltd.Bloomden Dental Zirconia Blank & Dental Zirconia Pre…PDF
K2539532026-03-10Ivoclar Vivadent, Inc.IPS e.max ZirconiaPDF
K2542832026-01-30Prismatik Dentalcraft, Inc.BruxZir® Shaded 16 PLUSPDF
K2539732026-01-09Liaoning Upcera Co., Ltd.Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, …PDF
K2527892025-12-08Shenzhen Xiangtong Co., Ltd.Glass CeramicPDF
K2524462025-09-03Prismatik Dentalcraft, Inc.BruxZir® NOWFDA
K2515932025-08-25Denmat Holding, LLCDenMat Multilayered Zirconia DiscFDA
K2500632025-07-10Arum Dentistry Co., Ltd.ARENA Star, Galaxy StarPDF
K2508262025-06-12Dmax Co., Ltd.Multi M SeriesPDF
K2510842025-06-05Estetic Ceram AGzirkon; structure; LFU shades, stains and glazesPDF
K2506732025-05-29Kuraray Noritake Dental, Inc.CERABIEN MiLaiPDF
K2505342025-05-20Aidite (Qinhuangdao) Technology Co., L…Biomic Color OpaquePDF
K2503932025-05-12United ZirconiaZircaGlow & ZircaGlow HT ZirconiaPDF
K2508112025-04-11Aidite (Qinhuangdao) Technology Co., L…Dental Zirconia CeramicPDF
K2500252025-03-14Aidite (Qinhuangdao) Technology Co., L…Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain…PDF
K2502232025-02-25Prismatik Dentalcraft, Inc.BruxZir® Esthetic NOWPDF
K2439402025-02-21Vita Zahnfabrik H.Rauter GmbH & Co.VITA YZ Multi TranslucentPDF
K2427402024-12-05Liaoning Rachcera Material Technology …Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT,…PDF
K2425212024-11-20Osstem Implant Co., Ltd.Estar-ZEPDF
K2424072024-11-13Hunan Vsmile Biotechnology Co., Ltd.Dental Glass Ceramics Blocks (HT, LT, MT)PDF
K2424622024-10-24Dentsply SironaCEREC Cercon 4D CAD/CAM BlocksPDF
K2424582024-10-24Argen CorporationArgenZ MTZFDA
K2424002024-10-10Yilink (Tianjin) Biotechnology Co., Lt…Dental porcelain powderFDA
K2411512024-09-30Dentalmax Co., Ltd.LUXEN 5GPDF
K2330642024-09-18Whitepeaks Dental Solutions GmbHCopra SupremePDF
K2415792024-09-06Dental Direkt GmbHDD Hybridlayer (multicolored zirconia)PDF
K2416022024-08-30Hunan Qinghao Puzhong Technology Co., …Kingcera Dental Zirconia BlankPDF
K2415572024-08-28Dentsply SironaCercon® yo MLFDA
K2417152024-07-12Aidite (Qinhuangdao) Technology Co., L…Dental Glass Ceramics Blocks (HT,LT,ST)PDF
K2413162024-07-09Hunan Hualian Special Ceramics Co., Lt…Zirconia BlockPDF
K2329522024-06-24Whitepeaks Dental Solutions GmbHCopran ZriPDF
K2338852024-06-21Genoss Co., Ltd.rainbow Paste Stain SEPDF
K2331582024-06-20Whitepeaks Dental Solutions GmbHCopra Smile, Copra Supreme HyperionFDA
K2406722024-06-07Zhejiang Zahndent Biotechnology Co., L…Dental Zirconia Blank & Dental Zirconia Pre-Shaded B…PDF
K2409122024-05-31Anhui Miisen Intelligence Technology C…Dental Zirconia Block (Models HT-plus, ST, SHT, UT, …PDF
K2407722024-05-20Hunan Ceramaster Material Technology C…Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C,…FDA
K2408822024-05-01Prismatik Dentalcraft, Inc.BruxZir® EstheticFDA
K2404192024-04-12Boston Micro FabricationUltraThineer Zirconia Slurry (5Y-B)PDF
K2405742024-03-20Prismatik Dentalcraft, Inc.BruxZir® RadiantPDF
K2326822024-03-19Chengdu Besmile Medical Technology Co.…Pre-Sintered Zirconia Coloring LiquidPDF
K2340142024-02-27Prismatik Dentalcraft, Inc.Obsidian® NOWPDF
K2321742024-02-23Genoss Co., Ltd.rainbowTM Multi-Layer Block / bright 3-Layer / brigh…PDF
K2326732024-01-23Chengdu Besmile Medical Technology Co.…Dental Glass CeramicsPDF
K2326762024-01-23Chengdu Besmile Medical Technology Co.…Dental Porcelain PowderPDF
K2331252024-01-12Hangzhou Ivista Medical Devices Co., L…Zirconia BlockPDF
K2330162023-12-21Shenzhen Yurucheng Dental Materials Co…Dental Glass CeramicsPDF
K2324382023-12-01Aibodent Biotechnology Co., Ltd.Dental Glass Ceramics BlocksPDF

其中 47 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: EIH
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。