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 Prismatik Dentalcraft, Inc., Aidite (Qinhuangdao) Technology Co., Ltd. and Chengdu Besmile Medical Technology Co., Ltd..
479
Total
479
Cleared
111d
Avg days
1977
Since
479 devices
Cleared
Feb 27, 2023
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
Arum Dentistry Co., Ltd.
Dental
129d
Cleared
Sep 23, 2022
Esthetic Colorant
Kuraray Noritake Dental, Inc.
Dental
227d
Cleared
Aug 02, 2022
BruxZir NOW
Prismatik Dentalcraft, Inc.
Dental
134d
Cleared
Jun 29, 2022
BruxZir Opaque Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
89d
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
Nov 17, 2021
BruxZir Esthetic
Prismatik Dentalcraft, Inc.
Dental
27d
Cleared
Aug 20, 2021
IPS e.max One
Ivoclar Vivadent, AG
Dental
60d
Cleared
Jul 02, 2021
Estar-Z
Osstem Implant Co., Ltd.
Dental
169d
Cleared
Jan 20, 2021
Dentsply Sirona Universal Spray Glazes
Dentsply Sirona
Dental
131d