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 |
|---|---|---|---|
| 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 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 |
| K242458 | ArgenZ MTZ | Argen Corporation | 2024-10-24 |
| K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024-10-10 |
| K241151 | LUXEN 5G | Dentalmax Co., Ltd. | 2024-09-30 |
| K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | 2024-09-18 |
| K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH | 2024-09-06 |
| K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. | 2024-08-30 |
| K241557 | Cercon® yo ML | Dentsply Sirona | 2024-08-28 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 06976581410016 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410023 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410030 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410047 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410054 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410061 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410078 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 06976581410009 | Dental Zirconia Blank | Hunan Haoci Material Technology Co., Ltd | 2026-06-06 |
| 07630031701541 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Institut Straumann AG | 2022-04-14 |
| 07630031701534 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Institut Straumann AG | 2022-04-14 |
| 07630031701510 | LAVA FRAME, LAVA FRAME SHADE, LAVA CERAM | Institut Straumann AG | 2022-04-14 |
| 07630031701398 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701442 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701435 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701428 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701411 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701404 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701381 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701374 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701367 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701350 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701343 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701329 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031701282 | Zerion Alpha, Zerion Beta | Institut Straumann AG | 2019-08-14 |
| 07630031734853 | n!ce Glass Ceramic Blocks | Institut Straumann AG | 2019-07-11 |
| 07630031731012 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | 2019-06-18 |
| 07630031731029 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | 2019-06-18 |
| 07630031731050 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | 2019-06-18 |
| 07630031731067 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | 2019-06-18 |
| 07630031731081 | n!ce Glass Ceramic Blocks for Amann Girrbach | Institut Straumann AG | 2019-06-18 |