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 |
|---|---|---|---|
| K262074 | Any-Zircos | Mediclus Co., Ltd. | 2026-08-21 |
| K262239 | Obsidian® Press Over Zirconia | Prismatik Dentalcraft, Inc. | 2026-07-30 |
| K261046 | Dental Zirconia Blank & Coloring Liquid | Hunan Qinghao Puzhong Technology Co., Ltd. | 2026-07-17 |
| K262195 | Dandy Ceramic Stain and Glaze | Zima International Inc., dba Dandy | 2026-06-30 |
| K260918 | Zolid Lunaris | Amann Girrbach AG | 2026-06-29 |
| K260859 | Rosetta SM, Rosetta SP | Hass Corp. | 2026-06-11 |
| 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 |
| K242458 | ArgenZ MTZ | Argen Corporation | 2024-10-24 |
| K242462 | CEREC Cercon 4D CAD/CAM Blocks | Dentsply Sirona | 2024-10-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| D800ZRTA106170 | Prettau 5 106H17 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106310 | Prettau 5 106H31 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106300 | Prettau 5 106H30 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106290 | Prettau 5 106H29 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106280 | Prettau 5 106H28 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106270 | Prettau 5 106H27 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106260 | Prettau 5 106H26 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106250 | Prettau 5 106H25 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106240 | Prettau 5 106H24 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106230 | Prettau 5 106H23 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106220 | Prettau 5 106H22 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106210 | Prettau 5 106H21 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106200 | Prettau 5 106H20 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106190 | Prettau 5 106H19 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106180 | Prettau 5 106H18 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09010 | Prettau 5 98H10 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106160 | Prettau 5 106H16 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106150 | Prettau 5 106H15 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106140 | Prettau 5 106H14 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106130 | Prettau 5 106H13 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106120 | Prettau 5 106H12 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106110 | Prettau 5 106H11 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA106100 | Prettau 5 106H10 | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09710 | Prettau 5 98H25 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09620 | Prettau 5 98H16 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09510 | Prettau 5 98H22 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09410 | Prettau 5 98H12 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09310 | Prettau 5 98H20 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09210 | Prettau 5 98H18 with step | ZIRKONZAHN SRL | 2026-09-18 |
| D800ZRTA09110 | Prettau 5 98H14 with step | ZIRKONZAHN SRL | 2026-09-18 |