Powder, Porcelain
Regulation 872.6660
17510(k)s in 12 months (491 all time)
1recalls in 12 months (35 all time)
35recalls that name a 510(k)
Top companies in EIH
| Company | 510(k)s | Recalls |
|---|---|---|
| Ivoclar Vivadent, AG | 9 | 32 |
| Dentsply Intl. | 23 | 0 |
| Prismatik Dentalcraft, Inc. | 21 | 1 |
| Vident | 16 | 0 |
| Shofu Dental Corp. | 15 | 0 |
| Noritake Co., Inc. | 14 | 0 |
| Wieland Dental + Technik GmbH & Co. KG | 14 | 0 |
| Jensen Industries, Inc. | 11 | 0 |
| Kuraray Noritake Dental, Inc. | 11 | 0 |
| Genoss | 10 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Mar 20, 2024 | K240574 | BruxZir® Radiant Prismatik Dentalcraft, Inc. | EIH |
| Mar 19, 2024 | K232682 | Pre-Sintered Zirconia Coloring Liquid Chengdu Besmile Medical Technology Co., Ltd., CN | EIH |
| Feb 27, 2024 | K234014 | Obsidian® NOW Prismatik Dentalcraft, Inc. | EIH |
| Feb 23, 2024 | K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono Genoss Co., Ltd., KR | EIH |
| Jan 23, 2024 | K232676 | Dental Porcelain Powder Chengdu Besmile Medical Technology Co., Ltd., CN | EIH |
| Jan 23, 2024 | K232673 | Dental Glass Ceramics Chengdu Besmile Medical Technology Co., Ltd., CN | EIH |
| Jan 12, 2024 | K233125 | Zirconia Block Hangzhou Ivista Medical Devices Co., Ltd., CN | EIH |
| Dec 21, 2023 | K233016 | Dental Glass Ceramics Shenzhen Yurucheng Dental Materials Co., Ltd., CN | EIH |
| Dec 1, 2023 | K232438 | Dental Glass Ceramics Blocks Aibodent Biotechnology Co., Ltd., CN | EIH |
| Sep 7, 2023 | K231687 | Gradual Dental Zirconia Blank Liaoning Upcera Co., Ltd., CN | EIH |
| Jul 3, 2023 | K230487 | Dental Lithium Disilicate Glass-Ceramic Fuzhou Rick Brown Biomaterials Co., Ltd., CN | EIH |
| Jun 30, 2023 | K231264 | Easy On Universal Glaze & Stain Doctus Global, KR | EIH |
| Jun 20, 2023 | K223029 | Perfit CL Vatech Mcis Co., Ltd., KR | EIH |
| Jun 9, 2023 | K231347 | BruxZir TintEFX Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| Jun 2, 2023 | K222961 | Harvest Conceal ZR Block Out Harvest Dental Products, LLC | EIH |
| May 25, 2023 | K230259 | Soreal Press, Soreal CAD Shenzhen Up3D Technology Co., Ltd., CN | EIH |
| May 16, 2023 | K230262 | BruxZir Incisal Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| Mar 31, 2023 | K230003 | Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Topzir Biotech Co., Ltd., CN | EIH |
| Mar 27, 2023 | K223192 | XT Stain/Glaze Shenzhen Xiangtong Co., Ltd., CN | EIH |
| Feb 27, 2023 | K223253 | Non-Sterile Zirconia Block (ARENA Star, Mont Blanc) Arum Dentistry Co., Ltd., KR | EIH |
| Feb 10, 2023 | K223194 | Glass Ceramic Shenzhen Xiangtong Co., Ltd., CN | EIH |
| Feb 10, 2023 | K222513 | Glass Ceramics Yilink (Tianjin) Biotechnology Co., Ltd., CN | EIH |
| Dec 14, 2022 | K213722 | ICE Ceramics, ICE Stains, Fresco Zirkonzahn Srl, IT | EIH |
| Dec 6, 2022 | K222626 | Dental Zirconia Ceramic Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Nov 14, 2022 | K222520 | Zirconia Block Yilink (Tianjin) Biotechnology Co., Ltd., CN | EIH |
| Oct 6, 2022 | K222686 | Perfit FS Dental Zirconia Fully Sintered Block Vatech Acucera, Inc., KR | EIH |
| Sep 23, 2022 | K220369 | Esthetic Colorant Kuraray Noritake Dental, Inc., JP | EIH |
| Aug 2, 2022 | K220816 | BruxZir NOW Prismatik Dentalcraft, Inc. | EIH |
| Jul 29, 2022 | K221242 | Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Hunan Vsmile Biotechnology Co., Ltd., CN | EIH |
| Jul 14, 2022 | K221429 | KDF Zirconia Disc Denken-Highdental Co., Ltd., JP | EIH |
| Jul 8, 2022 | K221051 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Changsha Honchon Technology Co., Ltd., CN | EIH |
| Jun 29, 2022 | K220960 | BruxZir Opaque Coloring Liquid Prismatik Dentalcraft, Inc. | EIH |
| Jun 29, 2022 | K220017 | Coloring Liquid Dongguan Xiangtong Co., Ltd., CN | EIH |
| Mar 28, 2022 | K213147 | CERABIEN MiLai Kuraray Noritake Dental, Inc., JP | EIH |
| Mar 18, 2022 | K212939 | Vintage Prime Press Shofu Dental Corporation | EIH |
| Feb 18, 2022 | K214005 | Zirconia Dental Ceramics Shenzhen Yurucheng Dental Materials Co., Ltd., CN | EIH |
| Feb 18, 2022 | K214003 | Dental Zirconia Pre-shaded Block Shenzhen Yurucheng Dental Materials Co., Ltd., CN | EIH |
| Jan 7, 2022 | K213570 | Dental Zirconia Ceramic Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Dec 6, 2021 | K212548 | LUXEN CL Dental Liquid Dentalmax Co., Ltd., KR | EIH |
| Nov 17, 2021 | K213425 | BruxZir Esthetic Prismatik Dentalcraft, Inc. | EIH |
| Nov 15, 2021 | K212765 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Bloomden Bioceramics (HuNan) Co., Ltd., CN | EIH |
| Nov 12, 2021 | K212259 | Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Zirdent New Material Co., Ltd., CN | EIH |
| Oct 4, 2021 | K211308 | INNI-CERA Aon Co., Ltd., KR | EIH |
| Aug 26, 2021 | K202952 | Amber Mill Q Series & Amber Mill Direct Series Hass Corp., KR | EIH |
| Aug 20, 2021 | K211916 | IPS e.max One Ivoclar Vivadent, AG, LI | EIH |
| Jul 27, 2021 | K210884 | 1Derful HS, 1Derful HT 1derful, Inc. | EIH |
| Jul 2, 2021 | K210097 | Estar-Z Osstem Implant Co., Ltd., KR | EIH |
| Jul 1, 2021 | K203672 | MAZIC Claro CAD and MAZIC Claro Press Vericom Co., Ltd., KR | EIH |
| Jun 24, 2021 | K203590 | Perfit FS Dental Zirconia Fully Sintered Block Vatech Acucera, Inc., KR | EIH |
| Apr 5, 2021 | K203499 | Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank Vatech Acucera, Inc., KR | EIH |
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