EIH
- 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)
- 487 件
该代码近三年的 510(k)（55 件）
| 510(k) 号 | 批准日期 | 申请人 | 器械名称 |
|---|---|---|---|
| K262074 | 2026-08-21 | Mediclus Co., Ltd. | Any-Zircos 摘要 |
| K262239 | 2026-07-30 | Prismatik Dentalcraft, Inc. | Obsidian® Press Over Zirconia 摘要 |
| K261046 | 2026-07-17 | Hunan Qinghao Puzhong Technology Co., | Dental Zirconia Blank & Coloring Liquid 摘要 |
| K262195 | 2026-06-30 | Zima International Inc., dba Dandy | Dandy Ceramic Stain and Glaze 摘要 |
| K260918 | 2026-06-29 | Amann Girrbach AG | Zolid Lunaris 摘要 |
| K260859 | 2026-06-11 | Hass Corp. | Rosetta SM, Rosetta SP 摘要 |
| K253191 | 2026-05-21 | Dental Creativ Management GmbH | DCMhotbond zircon 摘要 |
| K260067 | 2026-04-09 | Shandong Huge Dental Material Corporat | Eternal Art Porcelain Powders 摘要 |
| K260370 | 2026-03-30 | Bloomden Bioceramics (HuNan) Co., Ltd. | Bloomden Dental Zirconia Blank & Dental Zirconia Pre 摘要 |
| K253953 | 2026-03-10 | Ivoclar Vivadent, Inc. | IPS e.max Zirconia 摘要 |
| K254283 | 2026-01-30 | Prismatik Dentalcraft, Inc. | BruxZir® Shaded 16 PLUS 摘要 |
| K253973 | 2026-01-09 | Liaoning Upcera Co., Ltd. | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, 摘要 |
| K252789 | 2025-12-08 | Shenzhen Xiangtong Co., Ltd. | Glass Ceramic 摘要 |
| K252446 | 2025-09-03 | Prismatik Dentalcraft, Inc. | BruxZir® NOW 摘要 |
| K251593 | 2025-08-25 | Denmat Holding, LLC | DenMat Multilayered Zirconia Disc 摘要 |
| K250063 | 2025-07-10 | Arum Dentistry Co., Ltd. | ARENA Star, Galaxy Star 摘要 |
| K250826 | 2025-06-12 | Dmax Co., Ltd. | Multi M Series 摘要 |
| K251084 | 2025-06-05 | Estetic Ceram AG | zirkon; structure; LFU shades, stains and glazes 摘要 |
| K250673 | 2025-05-29 | Kuraray Noritake Dental, Inc. | CERABIEN MiLai 摘要 |
| K250534 | 2025-05-20 | Aidite (Qinhuangdao) Technology Co., L | Biomic Color Opaque 摘要 |
| K250393 | 2025-05-12 | United Zirconia | ZircaGlow & ZircaGlow HT Zirconia 摘要 |
| K250811 | 2025-04-11 | Aidite (Qinhuangdao) Technology Co., L | Dental Zirconia Ceramic 摘要 |
| K250025 | 2025-03-14 | Aidite (Qinhuangdao) Technology Co., L | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain 摘要 |
| K250223 | 2025-02-25 | Prismatik Dentalcraft, Inc. | BruxZir® Esthetic NOW 摘要 |
| K243940 | 2025-02-21 | Vita Zahnfabrik H.Rauter GmbH & Co. | VITA YZ Multi Translucent 摘要 |
| K242740 | 2024-12-05 | Liaoning Rachcera Material Technology | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, 摘要 |
| K242521 | 2024-11-20 | Osstem Implant Co., Ltd. | Estar-ZE 摘要 |
| K242407 | 2024-11-13 | Hunan Vsmile Biotechnology Co., Ltd. | Dental Glass Ceramics Blocks (HT, LT, MT) 摘要 |
| K242462 | 2024-10-24 | Dentsply Sirona | CEREC Cercon 4D CAD/CAM Blocks 摘要 |
| K242458 | 2024-10-24 | Argen Corporation | ArgenZ MTZ 摘要 |
| K242400 | 2024-10-10 | Yilink (Tianjin) Biotechnology Co., Lt | Dental porcelain powder 摘要 |
| K241151 | 2024-09-30 | Dentalmax Co., Ltd. | LUXEN 5G 摘要 |
| K233064 | 2024-09-18 | Whitepeaks Dental Solutions GmbH | Copra Supreme 摘要 |
| K241579 | 2024-09-06 | Dental Direkt GmbH | DD Hybridlayer (multicolored zirconia) 摘要 |
| K241602 | 2024-08-30 | Hunan Qinghao Puzhong Technology Co., | Kingcera Dental Zirconia Blank 摘要 |
| K241557 | 2024-08-28 | Dentsply Sirona | Cercon® yo ML 摘要 |
| K241715 | 2024-07-12 | Aidite (Qinhuangdao) Technology Co., L | Dental Glass Ceramics Blocks (HT,LT,ST) 摘要 |
| K241316 | 2024-07-09 | Hunan Hualian Special Ceramics Co., Lt | Zirconia Block 摘要 |
| K232952 | 2024-06-24 | Whitepeaks Dental Solutions GmbH | Copran Zri 摘要 |
| K233885 | 2024-06-21 | Genoss Co., Ltd. | rainbow Paste Stain SE 摘要 |
| K233158 | 2024-06-20 | Whitepeaks Dental Solutions GmbH | Copra Smile, Copra Supreme Hyperion 摘要 |
| K240672 | 2024-06-07 | Zhejiang Zahndent Biotechnology Co., L | Dental Zirconia Blank & Dental Zirconia Pre-Shaded B 摘要 |
| K240912 | 2024-05-31 | Anhui Miisen Intelligence Technology C | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 摘要 |
| K240772 | 2024-05-20 | Hunan Ceramaster Material Technology C | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, 摘要 |
| K240882 | 2024-05-01 | Prismatik Dentalcraft, Inc. | BruxZir® Esthetic 摘要 |
| K240419 | 2024-04-12 | Boston Micro Fabrication | UltraThineer Zirconia Slurry (5Y-B) 摘要 |
| K240574 | 2024-03-20 | Prismatik Dentalcraft, Inc. | BruxZir® Radiant 摘要 |
| K232682 | 2024-03-19 | Chengdu Besmile Medical Technology Co. | Pre-Sintered Zirconia Coloring Liquid 摘要 |
| K234014 | 2024-02-27 | Prismatik Dentalcraft, Inc. | Obsidian® NOW 摘要 |
| K232174 | 2024-02-23 | Genoss Co., Ltd. | rainbowTM Multi-Layer Block / bright 3-Layer / brigh 摘要 |
| K232673 | 2024-01-23 | Chengdu Besmile Medical Technology Co. | Dental Glass Ceramics 摘要 |
| K232676 | 2024-01-23 | Chengdu Besmile Medical Technology Co. | Dental Porcelain Powder 摘要 |
| K233125 | 2024-01-12 | Hangzhou Ivista Medical Devices Co., L | Zirconia Block 摘要 |
| K233016 | 2023-12-21 | Shenzhen Yurucheng Dental Materials Co | Dental Glass Ceramics 摘要 |
| K232438 | 2023-12-01 | Aibodent Biotechnology Co., Ltd. | Dental Glass Ceramics Blocks 摘要 |
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。