EIH · Class II · 21 CFR 872.6660

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
73–96 of 480
Cleared Mar 28, 2022
CERABIEN MiLai
K213147
Kuraray Noritake Dental, Inc.
Dental · 182d
Cleared Mar 18, 2022
Vintage Prime Press
K212939
Shofu Dental Corporation
Dental · 184d
Cleared Feb 18, 2022
Dental Zirconia Pre-shaded Block
K214003
Shenzhen Yurucheng Dental Materials Co., Ltd.
Dental · 59d
Cleared Feb 18, 2022
Zirconia Dental Ceramics
K214005
Shenzhen Yurucheng Dental Materials Co., Ltd.
Dental · 59d
Cleared Jan 07, 2022
Dental Zirconia Ceramic
K213570
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 58d
Cleared Dec 06, 2021
LUXEN CL Dental Liquid
K212548
Dentalmax Co., Ltd.
Dental · 115d
Cleared Nov 17, 2021
BruxZir Esthetic
K213425
Prismatik Dentalcraft, Inc.
Dental · 27d
Cleared Nov 15, 2021
Bloomden Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212765
Bloomden Bioceramics (Hunan) Co., Ltd.
Dental · 76d
Cleared Nov 12, 2021
Zirdent Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K212259
Zirdent New Material Co., Ltd.
Dental · 115d
Cleared Oct 04, 2021
INNI-CERA
K211308
Aon Co., Ltd.
Dental · 158d
Cleared Aug 26, 2021
Amber Mill Q Series & Amber Mill Direct Series
K202952
Hass Corp.
Dental · 330d
Cleared Aug 20, 2021
IPS e.max One
K211916
Ivoclar Vivadent, AG
Dental · 60d
Cleared Jul 27, 2021
1Derful HS, 1Derful HT
K210884
1derful, Inc.
Dental · 124d
Cleared Jul 02, 2021
Estar-Z
K210097
Osstem Implant Co., Ltd.
Dental · 169d
Cleared Jul 01, 2021
MAZIC Claro CAD and MAZIC Claro Press
K203672
Vericom Co., Ltd.
Dental · 197d
Cleared Jun 24, 2021
Perfit FS Dental Zirconia Fully Sintered Block
K203590
Vatech Acucera, Inc.
Dental · 198d
Cleared Apr 05, 2021
Perfit ZR ST Dental Zirconia blank, Perfit ZR UT Dental Zirconia blank
K203499
Vatech Acucera, Inc.
Dental · 129d
Cleared Mar 10, 2021
Non-Sterile Zirconia Block
K201492
Bioden Co., Ltd.
Dental · 279d
Cleared Mar 08, 2021
Perfit ZR HT Dental Zirconia blank
K203351
Vatech Acucera, Inc.
Dental · 115d
Cleared Feb 23, 2021
GenesisZr 4Y+ (ST1100) Zirconia
K201915
United Dental Resources Corporation
Dental · 228d
Cleared Jan 28, 2021
GenesisZr UHT700 Zirconia
K201608
United Dental Resources Corporation
Dental · 227d
Cleared Jan 20, 2021
Dentsply Sirona Universal Spray Glazes
K202629
Dentsply Sirona
Dental · 131d
Cleared Dec 10, 2020
X-cera Pre-shaded Zirconia Blanks
K202673
Dongguan Xiangtong Co., Ltd.
Dental · 86d
Cleared Oct 29, 2020
HCG Zirconia Ceramic Block
K193090
Hocheng Corporation
Dental · 358d