FDA Product Code
FDA Product Code EIH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.6660
510(k) Clearances — 487 records · page 1 of 5
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026-08-21 | Traditional | PDF ↗ |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 | Special | PDF ↗ |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 | Traditional | PDF ↗ |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 | Traditional | PDF ↗ |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 | Traditional | PDF ↗ |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 | Traditional | PDF ↗ |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 | Traditional | PDF ↗ |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026-04-09 | Traditional | PDF ↗ |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 | Traditional | PDF ↗ |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 | Traditional | PDF ↗ |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 | Special | PDF ↗ |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | 2026-01-09 | Special | PDF ↗ |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 | Abbreviated | PDF ↗ |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 | Special | PDF ↗ |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025-08-25 | Traditional | PDF ↗ |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 | Traditional | PDF ↗ |
| K250826 | Multi M Series | Dmax Co., Ltd. | 2025-06-12 | Traditional | PDF ↗ |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025-06-05 | Abbreviated | PDF ↗ |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 | Traditional | PDF ↗ |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 | Traditional | PDF ↗ |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | 2025-05-12 | Traditional | PDF ↗ |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-11 | Special | PDF ↗ |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-03-14 | Traditional | PDF ↗ |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | 2025-02-25 | Special | PDF ↗ |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025-02-21 | Traditional | PDF ↗ |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co., Ltd. | 2024-12-05 | Traditional | PDF ↗ |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024-11-20 | Traditional | PDF ↗ |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | 2024-11-13 | Traditional | PDF ↗ |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 | Traditional | PDF ↗ |
| K242458 | ArgenZ MTZ | Argen Corporation | 2024-10-24 | Traditional | PDF ↗ |
| K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024-10-10 | Traditional | PDF ↗ |
| K241151 | LUXEN 5G | Dentalmax Co., Ltd. | 2024-09-30 | Traditional | PDF ↗ |
| K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | 2024-09-18 | Traditional | PDF ↗ |
| K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH | 2024-09-06 | Traditional | PDF ↗ |
| K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. | 2024-08-30 | Traditional | PDF ↗ |
| K241557 | Cercon® yo ML | Dentsply Sirona | 2024-08-28 | Traditional | PDF ↗ |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-07-12 | Special | PDF ↗ |
| K241316 | Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd. | 2024-07-09 | Traditional | PDF ↗ |
| K232952 | Copran Zri | Whitepeaks Dental Solutions GmbH | 2024-06-24 | Traditional | PDF ↗ |
| K233885 | rainbow Paste Stain SE | Genoss Co., Ltd. | 2024-06-21 | Traditional | PDF ↗ |
| K233158 | Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH | 2024-06-20 | Traditional | PDF ↗ |
| K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML) | Zhejiang Zahndent Biotechnology Co., Ltd. | 2024-06-07 | Traditional | PDF ↗ |
| K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | 2024-05-31 | Traditional | PDF ↗ |
| K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML) | Hunan Ceramaster Material Technology Co., Ltd. | 2024-05-20 | Traditional | PDF ↗ |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | 2024-05-01 | Special | PDF ↗ |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication | 2024-04-12 | Traditional | PDF ↗ |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. | 2024-03-20 | Special | PDF ↗ |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | 2024-03-19 | Traditional | PDF ↗ |
| K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | 2024-02-27 | Traditional | PDF ↗ |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. | 2024-02-23 | Traditional | PDF ↗ |
| K232676 | Dental Porcelain Powder | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 | Traditional | PDF ↗ |
| K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 | Traditional | PDF ↗ |
| K233125 | Zirconia Block | Hangzhou Ivista Medical Devices Co., Ltd. | 2024-01-12 | Traditional | PDF ↗ |
| K233016 | Dental Glass Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2023-12-21 | Traditional | PDF ↗ |
| K232438 | Dental Glass Ceramics Blocks | Aibodent Biotechnology Co., Ltd. | 2023-12-01 | Traditional | PDF ↗ |
| K231687 | Gradual Dental Zirconia Blank | Liaoning Upcera Co., Ltd. | 2023-09-07 | Traditional | PDF ↗ |
| K230487 | Dental Lithium Disilicate Glass-Ceramic | Fuzhou Rick Brown Biomaterials Co., Ltd. | 2023-07-03 | Traditional | PDF ↗ |
| K231264 | Easy On Universal Glaze & Stain | Doctus Global | 2023-06-30 | Traditional | PDF ↗ |
| K223029 | Perfit CL | Vatech Mcis Co., Ltd. | 2023-06-20 | Traditional | PDF ↗ |
| K231347 | BruxZir TintEFX Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023-06-09 | Special | PDF ↗ |
| K222961 | Harvest Conceal ZR Block Out | Harvest Dental Products, LLC | 2023-06-02 | Traditional | PDF ↗ |
| K230259 | Soreal Press, Soreal CAD | Shenzhen Up3D Technology Co., Ltd. | 2023-05-25 | Traditional | PDF ↗ |
| K230262 | BruxZir Incisal Coloring Liquid | Prismatik Dentalcraft, Inc. | 2023-05-16 | Traditional | PDF ↗ |
| K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Topzir Biotech Co., Ltd. | 2023-03-31 | Traditional | PDF ↗ |
| K223192 | XT Stain/Glaze | Shenzhen Xiangtong Co., Ltd. | 2023-03-27 | Traditional | PDF ↗ |
| K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) | Arum Dentistry Co., Ltd. | 2023-02-27 | Traditional | PDF ↗ |
| K223194 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K222513 | Glass Ceramics | Yilink (Tianjin) Biotechnology Co., Ltd. | 2023-02-10 | Traditional | PDF ↗ |
| K213722 | ICE Ceramics, ICE Stains, Fresco | Zirkonzahn Srl | 2022-12-14 | Traditional | PDF ↗ |
| K222626 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2022-12-06 | Traditional | PDF ↗ |
| K222520 | Zirconia Block | Yilink (Tianjin) Biotechnology Co., Ltd. | 2022-11-14 | Traditional | PDF ↗ |
| K222686 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2022-10-06 | Special | PDF ↗ |
| K220369 | Esthetic Colorant | Kuraray Noritake Dental, Inc. | 2022-09-23 | Traditional | PDF ↗ |
| K220816 | BruxZir NOW | Prismatik Dentalcraft, Inc. | 2022-08-02 | Traditional | PDF ↗ |
| K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Hunan Vsmile Biotechnology Co., Ltd. | 2022-07-29 | Traditional | PDF ↗ |
| K221429 | KDF Zirconia Disc | Denken-Highdental Co., Ltd. | 2022-07-14 | Traditional | PDF ↗ |
| K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Changsha Honchon Technology Co., Ltd. | 2022-07-08 | Traditional | PDF ↗ |
| K220960 | BruxZir Opaque Coloring Liquid | Prismatik Dentalcraft, Inc. | 2022-06-29 | Traditional | PDF ↗ |
| K220017 | Coloring Liquid | Dongguan Xiangtong Co., Ltd. | 2022-06-29 | Traditional | PDF ↗ |
| K213147 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2022-03-28 | Traditional | PDF ↗ |
| K212939 | Vintage Prime Press | Shofu Dental Corporation | 2022-03-18 | Traditional | PDF ↗ |
| K214003 | Dental Zirconia Pre-shaded Block | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K214005 | Zirconia Dental Ceramics | Shenzhen Yurucheng Dental Materials Co., Ltd. | 2022-02-18 | Traditional | PDF ↗ |
| K213570 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2022-01-07 | Traditional | PDF ↗ |
| K212548 | LUXEN CL Dental Liquid | Dentalmax Co., Ltd. | 2021-12-06 | Traditional | PDF ↗ |
| K213425 | BruxZir Esthetic | Prismatik Dentalcraft, Inc. | 2021-11-17 | Special | PDF ↗ |
| K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | 2021-11-15 | Traditional | PDF ↗ |
| K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Zirdent New Material Co., Ltd. | 2021-11-12 | Traditional | PDF ↗ |
| K211308 | INNI-CERA | Aon Co., Ltd. | 2021-10-04 | Traditional | PDF ↗ |
| K202952 | Amber Mill Q Series & Amber Mill Direct Series | Hass Corp. | 2021-08-26 | Traditional | PDF ↗ |
| K211916 | IPS e.max One | Ivoclar Vivadent, AG | 2021-08-20 | Traditional | PDF ↗ |
| K210884 | 1Derful HS, 1Derful HT | 1derful, Inc. | 2021-07-27 | Traditional | PDF ↗ |
| K210097 | Estar-Z | Osstem Implant Co., Ltd. | 2021-07-02 | Traditional | PDF ↗ |
| K203672 | MAZIC Claro CAD and MAZIC Claro Press | Vericom Co., Ltd. | 2021-07-01 | Traditional | PDF ↗ |
| K203590 | Perfit FS Dental Zirconia Fully Sintered Block | Vatech Acucera, Inc. | 2021-06-24 | Traditional | PDF ↗ |
| K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank | Vatech Acucera, Inc. | 2021-04-05 | Traditional | PDF ↗ |
| K201492 | Non-Sterile Zirconia Block | Bioden Co., Ltd. | 2021-03-10 | Traditional | PDF ↗ |
| K203351 | Perfit ZR HT Dental Zirconia blank | Vatech Acucera, Inc. | 2021-03-08 | Traditional | PDF ↗ |
| K201915 | GenesisZr 4Y+ (ST1100) Zirconia | United Dental Resources Corporation | 2021-02-23 | Traditional | PDF ↗ |
| K201608 | GenesisZr UHT700 Zirconia | United Dental Resources Corporation | 2021-01-28 | Traditional | PDF ↗ |
Product code EIH · Class II · Dental. Data: openFDA.