Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
EIH — Predicate Candidate Screening
486 FDA 510(k) clearances under this product code; the 50 most recent screened below.
87 daysmedian FDA review time
230 days90th percentile
486clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 | 29 | 0 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 | 108 | 0 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 | 1 | 0 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 | 102 | 0 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 | 87 | 0 |
| K253191 | DCMhotbond zircon | Dental Creativ Management GmbH | 2026-05-21 | 237 | 0 |
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | 2026-04-09 | 90 | 0 |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded | Bloomden Bioceramics (HuNan) Co., Ltd. | 2026-03-30 | 53 | 0 |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | 2026-03-10 | 90 | 0 |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | 2026-01-30 | 30 | 0 |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP S | Liaoning Upcera Co., Ltd. | 2026-01-09 | 29 | 0 |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | 2025-12-08 | 97 | 0 |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | 2025-09-03 | 30 | 0 |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | 2025-08-25 | 90 | 0 |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | 2025-07-10 | 181 | 0 |
| K250826 | Multi M Series | Dmax Co., Ltd. | 2025-06-12 | 86 | 0 |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | 2025-06-05 | 57 | 0 |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | 2025-05-29 | 84 | 0 |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-05-20 | 85 | 0 |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | 2025-05-12 | 89 | 0 |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-04-11 | 25 | 0 |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A | Aidite (Qinhuangdao) Technology Co., Ltd. | 2025-03-14 | 67 | 0 |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | 2025-02-25 | 29 | 0 |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | 2025-02-21 | 63 | 0 |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML- | Liaoning Rachcera Material Technology Co., Ltd. | 2024-12-05 | 85 | 0 |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | 2024-11-20 | 89 | 0 |
| K242407 | Dental Glass Ceramics Blocks (HT, LT, MT) | Hunan Vsmile Biotechnology Co., Ltd. | 2024-11-13 | 91 | 0 |
| K242458 | ArgenZ MTZ | Argen Corporation | 2024-10-24 | 66 | 0 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 | 66 | 0 |
| K242400 | Dental porcelain powder | Yilink (Tianjin) Biotechnology Co., Ltd. | 2024-10-10 | 58 | 0 |
| K241151 | LUXEN 5G | Dentalmax Co., Ltd. | 2024-09-30 | 158 | 0 |
| K233064 | Copra Supreme | Whitepeaks Dental Solutions GmbH | 2024-09-18 | 358 | 0 |
| K241579 | DD Hybridlayer (multicolored zirconia) | Dental Direkt GmbH | 2024-09-06 | 95 | 0 |
| K241602 | Kingcera Dental Zirconia Blank | Hunan Qinghao Puzhong Technology Co., Ltd. | 2024-08-30 | 87 | 0 |
| K241557 | Cercon® yo ML | Dentsply Sirona | 2024-08-28 | 89 | 0 |
| K241715 | Dental Glass Ceramics Blocks (HT,LT,ST) | Aidite (Qinhuangdao) Technology Co., Ltd. | 2024-07-12 | 28 | 0 |
| K241316 | Zirconia Block | Hunan Hualian Special Ceramics Co., Ltd. | 2024-07-09 | 60 | 0 |
| K232952 | Copran Zri | Whitepeaks Dental Solutions GmbH | 2024-06-24 | 277 | 0 |
| K233885 | rainbow Paste Stain SE | Genoss Co., Ltd. | 2024-06-21 | 196 | 0 |
| K233158 | Copra Smile, Copra Supreme Hyperion | Whitepeaks Dental Solutions GmbH | 2024-06-20 | 267 | 0 |
| K240672 | Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( Z | Zhejiang Zahndent Biotechnology Co., Ltd. | 2024-06-07 | 88 | 0 |
| K240912 | Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro) | Anhui Miisen Intelligence Technology Co., Ltd. | 2024-05-31 | 58 | 0 |
| K240772 | Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, | Hunan Ceramaster Material Technology Co., Ltd. | 2024-05-20 | 60 | 0 |
| K240882 | BruxZir® Esthetic | Prismatik Dentalcraft, Inc. | 2024-05-01 | 30 | 0 |
| K240419 | UltraThineer Zirconia Slurry (5Y-B) | Boston Micro Fabrication | 2024-04-12 | 59 | 0 |
| K240574 | BruxZir® Radiant | Prismatik Dentalcraft, Inc. | 2024-03-20 | 19 | 0 |
| K232682 | Pre-Sintered Zirconia Coloring Liquid | Chengdu Besmile Medical Technology Co., Ltd. | 2024-03-19 | 200 | 0 |
| K234014 | Obsidian® NOW | Prismatik Dentalcraft, Inc. | 2024-02-27 | 70 | 0 |
| K232174 | rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono | Genoss Co., Ltd. | 2024-02-23 | 217 | 0 |
| K232673 | Dental Glass Ceramics | Chengdu Besmile Medical Technology Co., Ltd. | 2024-01-23 | 144 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda