FDA Product Code EIH: Powder, Porcelain
FDA product code EIH covers dental porcelain powders used in the fabrication of ceramic restorations.
These materials are used by dental technicians to build up layered porcelain restorations — including crowns, bridges, and veneers — that match the optical properties of natural tooth enamel. They are fired in a dental furnace to achieve the desired strength and translucency.
EIH devices are Class II medical devices, regulated under 21 CFR 872.6660 and reviewed by the FDA Dental panel.
Leading manufacturers include Dentsply Intl., Prismatik Dentalcraft, Inc. and Vident.
488
Total
488
Cleared
110d
Avg days
1977
Since
488 devices
Cleared
Mar 19, 2024
Pre-Sintered Zirconia Coloring Liquid
Chengdu Besmile Medical Technology Co., Ltd.
Dental
200d
Cleared
Feb 27, 2024
Obsidian® NOW
Prismatik Dentalcraft, Inc.
Dental
70d
Cleared
Feb 23, 2024
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
Genoss Co., Ltd.
Dental
217d
Cleared
Jan 23, 2024
Dental Glass Ceramics
Chengdu Besmile Medical Technology Co., Ltd.
Dental
144d
Cleared
Jan 23, 2024
Dental Porcelain Powder
Chengdu Besmile Medical Technology Co., Ltd.
Dental
144d
Cleared
Jan 12, 2024
Zirconia Block
Hangzhou Ivista Medical Devices Co., Ltd.
Dental
107d
Cleared
Dec 21, 2023
Dental Glass Ceramics
Shenzhen Yurucheng Dental Materials Co., Ltd.
Dental
90d
Cleared
Dec 01, 2023
Dental Glass Ceramics Blocks
Aibodent Biotechnology Co., Ltd.
Dental
109d
Cleared
Sep 07, 2023
Gradual Dental Zirconia Blank
Liaoning Upcera Co., Ltd.
Dental
90d
Cleared
Jul 03, 2023
Dental Lithium Disilicate Glass-Ceramic
Fuzhou Rick Brown Biomaterials Co., Ltd.
Dental
130d
Cleared
Jun 30, 2023
Easy On Universal Glaze & Stain
Doctus Global
Dental
59d
Cleared
Jun 20, 2023
Perfit CL
Vatech Mcis Co., Ltd.
Dental
264d
Cleared
Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
31d
Cleared
Jun 02, 2023
Harvest Conceal ZR Block Out
Harvest Dental Products, LLC
Dental
248d
Cleared
May 25, 2023
Soreal Press, Soreal CAD
Shenzhen Up3D Technology Co., Ltd.
Dental
114d
Cleared
May 16, 2023
BruxZir™ Incisal Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
105d
Cleared
Mar 31, 2023
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Topzir Biotech Co., Ltd.
Dental
87d
Cleared
Mar 27, 2023
XT Stain/Glaze
Shenzhen Xiangtong Co., Ltd.
Dental
165d
Cleared
Feb 27, 2023
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
Arum Dentistry Co., Ltd.
Dental
129d
Cleared
Feb 10, 2023
Glass Ceramics
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental
175d
Cleared
Feb 10, 2023
Glass Ceramic
Shenzhen Xiangtong Co., Ltd.
Dental
120d
Cleared
Dec 14, 2022
ICE Ceramics, ICE Stains, Fresco
Zirkonzahn Srl
Dental
383d
Cleared
Dec 06, 2022
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental
97d
Cleared
Nov 14, 2022
Zirconia Block
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental
87d