Product code EIH
- Device name
- Powder, Porcelain
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.6660
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026-08-21 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026-04-09 |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | 2026-01-09 |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025-08-25 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 |
| K250826 | Multi M Series | Dmax Co., Ltd. | 2025-06-12 |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025-06-05 |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | 2025-05-12 |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-11 |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-03-14 |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | 2025-02-25 |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025-02-21 |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co., Ltd. | 2024-12-05 |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024-11-20 |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | 2024-11-13 |
| K242458 | ArgenZ MTZ | Argen Corporation | 2024-10-24 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| J017BLSKV20 | VITA LUMEX® AC | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BLSKCV20 | VITA LUMEX® AC | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017LAMSKCV20 | VITA AMBRIA® | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BVMKSETCV30 | VITA VMK Master® | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV9MKV20 | VITA VM®9 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV9GKV20 | VITA VM®9 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV13MKV20 | VITA VM®13 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV13GKV20 | VITA VM®13 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV13BKS12V50 | VITA VM®13 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV13BK12V50 | VITA VM®13 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BV13BK12CV50 | VITA VM®13 | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| J017BLSTKCV20 | VITA LUMEX® AC | Vita - Zahnfabrik H. Rauter Gesellschaft mit beschränkter Haftung & Co Kommanditgesellschaft | 2026-09-24 |
| D818137893 | ArgenZ GT 98x20 B4 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137890 | ArgenZ GT 98x20 B1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137885 | ArgenZ GT 98x16 B4 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137882 | ArgenZ GT 98x16 B1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137877 | ArgenZ GT 98x12 B4 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137874 | ArgenZ GT 98x12 B1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137866 | ArgenZ GT 98x25 A3 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137865 | ArgenZ GT 98x25 A2 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137864 | ArgenZ GT 98x25 A1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137861 | ArgenZ GT 98x20 A3 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137860 | ArgenZ GT 98x20 A2 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137859 | ArgenZ GT 98x20 A1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137851 | ArgenZ GT 98x16 A3 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137850 | ArgenZ GT 98x16 A2 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137849 | ArgenZ GT 98x16 A1 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137841 | ArgenZ GT 98x12 A3 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137840 | ArgenZ GT 98x12 A2 | ARGEN CORPORATION, THE | 2026-01-15 |
| D818137839 | ArgenZ GT 98x12 A1 | ARGEN CORPORATION, THE | 2026-01-15 |