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 Aidite (Qinhuangdao) Technology Co., Ltd..
480
Total
480
Cleared
111d
Avg days
1977
Since
480 devices
Cleared
Mar 28, 2022
CERABIEN MiLai
Kuraray Noritake Dental, Inc.
Dental
182d
Cleared
Mar 18, 2022
Vintage Prime Press
Shofu Dental Corporation
Dental
184d
Cleared
Feb 18, 2022
Dental Zirconia Pre-shaded Block
Shenzhen Yurucheng Dental Materials Co., Ltd.
Dental
59d
Cleared
Feb 18, 2022
Zirconia Dental Ceramics
Shenzhen Yurucheng Dental Materials Co., Ltd.
Dental
59d
Cleared
Jan 07, 2022
Dental Zirconia Ceramic
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental
58d
Cleared
Dec 06, 2021
LUXEN CL Dental Liquid
Dentalmax Co., Ltd.
Dental
115d
Cleared
Nov 17, 2021
BruxZir Esthetic
Prismatik Dentalcraft, Inc.
Dental
27d
Cleared
Nov 15, 2021
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Bloomden Bioceramics (Hunan) Co., Ltd.
Dental
76d
Cleared
Nov 12, 2021
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Zirdent New Material Co., Ltd.
Dental
115d
Cleared
Oct 04, 2021
INNI-CERA
Aon Co., Ltd.
Dental
158d
Cleared
Aug 26, 2021
Amber Mill Q Series & Amber Mill Direct Series
Hass Corp.
Dental
330d
Cleared
Aug 20, 2021
IPS e.max One
Ivoclar Vivadent, AG
Dental
60d
Cleared
Jul 27, 2021
1Derful HS, 1Derful HT
1derful, Inc.
Dental
124d
Cleared
Jul 02, 2021
Estar-Z
Osstem Implant Co., Ltd.
Dental
169d
Cleared
Jul 01, 2021
MAZIC Claro CAD and MAZIC Claro Press
Vericom Co., Ltd.
Dental
197d
Cleared
Jun 24, 2021
Perfit FS Dental Zirconia Fully Sintered Block
Vatech Acucera, Inc.
Dental
198d
Cleared
Apr 05, 2021
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
Vatech Acucera, Inc.
Dental
129d
Cleared
Mar 10, 2021
Non-Sterile Zirconia Block
Bioden Co., Ltd.
Dental
279d
Cleared
Mar 08, 2021
Perfit ZR HT Dental Zirconia blank
Vatech Acucera, Inc.
Dental
115d
Cleared
Feb 23, 2021
GenesisZr 4Y+ (ST1100) Zirconia
United Dental Resources Corporation
Dental
228d
Cleared
Jan 28, 2021
GenesisZr UHT700 Zirconia
United Dental Resources Corporation
Dental
227d
Cleared
Jan 20, 2021
Dentsply Sirona Universal Spray Glazes
Dentsply Sirona
Dental
131d
Cleared
Dec 10, 2020
X-cera Pre-shaded Zirconia Blanks
Dongguan Xiangtong Co., Ltd.
Dental
86d
Cleared
Oct 29, 2020
HCG Zirconia Ceramic Block
Hocheng Corporation
Dental
358d