Powder, Porcelain
Regulation 872.6660
15510(k)s in 12 months (489 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 |
|---|---|---|---|
| Oct 21, 2026 | K262980 | INNI-CERA (BCM-W500, BCM-W1000) DentMedi Co., Ltd., KR | EIH |
| Oct 16, 2026 | K262523 | Amber Arte Hass Corp., KR | EIH |
| Aug 21, 2026 | K262074 | Any-Zircos Mediclus Co., Ltd., KR | EIH |
| Jul 30, 2026 | K262239 | Obsidian® Press Over Zirconia Prismatik Dentalcraft, Inc. | EIH |
| Jul 17, 2026 | K261046 | Dental Zirconia Blank & Coloring Liquid Hunan Qinghao Puzhong Technology Co., Ltd., CN | EIH |
| Jun 30, 2026 | K262195 | Dandy Ceramic Stain and Glaze Zima International Inc., dba Dandy | EIH |
| Jun 29, 2026 | K260918 | Zolid Lunaris Amann Girrbach AG, AT | EIH |
| Jun 11, 2026 | K260859 | Rosetta SM, Rosetta SP Hass Corp., KR | EIH |
| May 21, 2026 | K253191 | DCMhotbond zircon Dental Creativ Management GmbH, DE | EIH |
| Apr 9, 2026 | K260067 | Eternal Art Porcelain Powders Shandong Huge Dental Material Corporation, CN | EIH |
| Mar 30, 2026 | K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank Bloomden Bioceramics (HuNan) Co., Ltd., CN | EIH |
| Mar 10, 2026 | K253953 | IPS e.max Zirconia Ivoclar Vivadent, Inc. | EIH |
| Jan 30, 2026 | K254283 | BruxZir® Shaded 16 PLUS Prismatik Dentalcraft, Inc. | EIH |
| Jan 9, 2026 | K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series Liaoning Upcera Co., Ltd., CN | EIH |
| Dec 8, 2025 | K252789 | Glass Ceramic Shenzhen Xiangtong Co., Ltd., CN | EIH |
| Sep 3, 2025 | K252446 | BruxZir® NOW Prismatik Dentalcraft, Inc. | EIH |
| Aug 25, 2025 | K251593 | DenMat Multilayered Zirconia Disc Denmat Holding, LLC | EIH |
| Jul 10, 2025 | K250063 | ARENA Star, Galaxy Star Arum Dentistry Co., Ltd., KR | EIH |
| Jun 12, 2025 | K250826 | Multi M Series Dmax Co., Ltd., KR | EIH |
| Jun 5, 2025 | K251084 | zirkon; structure; LFU shades, stains and glazes Estetic Ceram AG, LI | EIH |
| May 29, 2025 | K250673 | CERABIEN MiLai Kuraray Noritake Dental, Inc., JP | EIH |
| May 20, 2025 | K250534 | Biomic Color Opaque Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| May 12, 2025 | K250393 | ZircaGlow & ZircaGlow HT Zirconia United Zirconia, EG | EIH |
| Apr 11, 2025 | K250811 | Dental Zirconia Ceramic Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Mar 14, 2025 | K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Feb 25, 2025 | K250223 | BruxZir® Esthetic NOW Prismatik Dentalcraft, Inc. | EIH |
| Feb 21, 2025 | K243940 | VITA YZ Multi Translucent Vita Zahnfabrik H.Rauter GmbH & Co., DE | EIH |
| Dec 5, 2024 | K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) Liaoning Rachcera Material Technology Co., Ltd., CN | EIH |
| Nov 20, 2024 | K242521 | Estar-ZE Osstem Implant Co., Ltd., KR | EIH |
| Nov 13, 2024 | K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) Hunan Vsmile Biotechnology Co., Ltd., CN | EIH |
| Oct 24, 2024 | K242462 | CEREC Cercon 4D CAD/CAM Blocks Dentsply Sirona | EIH |
| Oct 24, 2024 | K242458 | ArgenZ MTZ Argen Corporation | EIH |
| Oct 10, 2024 | K242400 | Dental porcelain powder Yilink (Tianjin) Biotechnology Co., Ltd., CN | EIH |
| Sep 30, 2024 | K241151 | LUXEN 5G Dentalmax Co., Ltd., KR | EIH |
| Sep 18, 2024 | K233064 | Copra Supreme Whitepeaks Dental Solutions GmbH, DE | EIH |
| Sep 6, 2024 | K241579 | DD Hybridlayer (multicolored zirconia) Dental Direkt GmbH, DE | EIH |
| Aug 30, 2024 | K241602 | Kingcera Dental Zirconia Blank Hunan Qinghao Puzhong Technology Co., Ltd., CN | EIH |
| Aug 28, 2024 | K241557 | Cercon® yo ML Dentsply Sirona | EIH |
| Jul 12, 2024 | K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) Aidite (Qinhuangdao) Technology Co., Ltd., CN | EIH |
| Jul 9, 2024 | K241316 | Zirconia Block Hunan Hualian Special Ceramics Co., Ltd., CN | EIH |
| Jun 24, 2024 | K232952 | Copran Zri Whitepeaks Dental Solutions GmbH, DE | EIH |
| Jun 21, 2024 | K233885 | rainbow Paste Stain SE Genoss Co., Ltd., KR | EIH |
| Jun 20, 2024 | K233158 | Copra Smile, Copra Supreme Hyperion Whitepeaks Dental Solutions GmbH, DE | EIH |
| Jun 7, 2024 | 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- Zhejiang Zahndent Biotechnology Co., Ltd., CN | EIH |
| May 31, 2024 | K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) Anhui Miisen Intelligence Technology Co., Ltd., CN | EIH |
| May 20, 2024 | 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., CN | EIH |
| May 1, 2024 | K240882 | BruxZir® Esthetic Prismatik Dentalcraft, Inc. | EIH |
| Apr 12, 2024 | K240419 | UltraThineer Zirconia Slurry (5Y-B) Boston Micro Fabrication | EIH |
| 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 |
Free CSV: newest 100 rows. Paid plans export up to 1,000 or 10,000 rows.