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
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
Cleared
Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
Vatech Acucera, Inc.
Dental
30d
Cleared
Sep 23, 2022
Esthetic Colorant
Kuraray Noritake Dental, Inc.
Dental
227d
Cleared
Aug 02, 2022
BruxZir NOW
Prismatik Dentalcraft, Inc.
Dental
134d
Cleared
Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Hunan Vsmile Biotechnology Co., Ltd.
Dental
88d
Cleared
Jul 14, 2022
KDF Zirconia Disc
Denken-Highdental Co., Ltd.
Dental
59d
Cleared
Jul 08, 2022
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
Changsha Honchon Technology Co., Ltd.
Dental
88d
Cleared
Jun 29, 2022
Coloring Liquid
Dongguan Xiangtong Co., Ltd.
Dental
175d
Cleared
Jun 29, 2022
BruxZir Opaque Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
89d