EIH · Powder, Porcelain
Dental · 21 CFR 872.6660 · Class 2
Overview
| Product Code | EIH |
|---|---|
| Device Name | Powder, Porcelain |
| Regulation | 21 CFR 872.6660 |
| Device Class | Class 2 |
| Review Panel | Dental |
| 3rd-Party Reviewable | Yes |
Identification
Porcelain powder for clinical use is a device consisting of a mixture of kaolin, felspar, quartz, or other substances intended for use in the production of artificial teeth in fixed or removable dentures, of jacket crowns, facings, and veneers. The device is used in prosthetic dentistry by heating the powder mixture to a high temperature in an oven to produce a hard prosthesis with a glass-like finish.
Classification Rationale
Class II.
Recent Cleared Devices (20 of 480)
Showing 20 most recent of 480 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K260067 | Eternal Art Porcelain Powders | Shandong Huge Dental Material Corporation | Apr 9, 2026 | SESE |
| K260370 | Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank | Bloomden Bioceramics (HuNan) Co., Ltd. | Mar 30, 2026 | SESE |
| K253953 | IPS e.max Zirconia | Ivoclar Vivadent, Inc. | Mar 10, 2026 | SESE |
| K254283 | BruxZir® Shaded 16 PLUS | Prismatik Dentalcraft, Inc. | Jan 30, 2026 | SESE |
| K253973 | Gradual Dental Zirconia Blank - GT(F) P1, GT(F) P2, and SP Series | Liaoning Upcera Co., Ltd. | Jan 9, 2026 | SESE |
| K252789 | Glass Ceramic | Shenzhen Xiangtong Co., Ltd. | Dec 8, 2025 | SESE |
| K252446 | BruxZir® NOW | Prismatik Dentalcraft, Inc. | Sep 3, 2025 | SESE |
| K251593 | DenMat Multilayered Zirconia Disc | Denmat Holding, LLC | Aug 25, 2025 | SESE |
| K250063 | ARENA Star, Galaxy Star | Arum Dentistry Co., Ltd. | Jul 10, 2025 | SESE |
| K250826 | Multi M Series | Dmax Co., Ltd. | Jun 12, 2025 | SESE |
| K251084 | zirkon; structure; LFU shades, stains and glazes | Estetic Ceram AG | Jun 5, 2025 | SESE |
| K250673 | CERABIEN MiLai | Kuraray Noritake Dental, Inc. | May 29, 2025 | SESE |
| K250534 | Biomic Color Opaque | Aidite (Qinhuangdao) Technology Co., Ltd. | May 20, 2025 | SESE |
| K250393 | ZircaGlow & ZircaGlow HT Zirconia | United Zirconia | May 12, 2025 | SESE |
| K250811 | Dental Zirconia Ceramic | Aidite (Qinhuangdao) Technology Co., Ltd. | Apr 11, 2025 | SESE |
| K250025 | Porcelain Powder (Enamel/ Modifier,Stain/Glaze,Stain/Glaze-A,Modeling Fluid ) | Aidite (Qinhuangdao) Technology Co., Ltd. | Mar 14, 2025 | SESE |
| K250223 | BruxZir® Esthetic NOW | Prismatik Dentalcraft, Inc. | Feb 25, 2025 | SESE |
| K243940 | VITA YZ Multi Translucent | Vita Zahnfabrik H.Rauter GmbH & Co. | Feb 21, 2025 | SESE |
| K242740 | Dental Lithium Disilicate Glass Ceramic ( HT, ML-HT, LT, ML-LT, MT, MO, HO) | Liaoning Rachcera Material Technology Co., Ltd. | Dec 5, 2024 | SESE |
| K242521 | Estar-ZE | Osstem Implant Co., Ltd. | Nov 20, 2024 | SESE |
Top Applicants
- Dentsply Intl. — 23 clearances
- Prismatik Dentalcraft, Inc. — 20 clearances
- Vident — 16 clearances
- Noritake Co., Inc. — 14 clearances
- Wieland Dental + Technik GmbH & Co. KG — 14 clearances
