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
Aug 18, 2020
Coloring Liquid
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental
326d
Cleared
Jul 21, 2020
VITA LUMEX AC
Vita Zahnfabrik GmbH H Rauter & CO
Dental
223d
Cleared
Jul 08, 2020
Dental Glass Ceramics Blocks
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental
327d
Cleared
Jun 10, 2020
BruxZir Steel
Prismatik Dentalcraft, Inc.
Dental
141d
Cleared
May 29, 2020
Dental Zirconia Blocks
De Corematrix Co., Ltd.
Dental
282d
Cleared
May 14, 2020
VITA Ambria
Vita Zahnfabrik GmbH H Rauter & CO
Dental
155d
Cleared
May 13, 2020
Purzir Dental Zirconia
3DBiocad
Dental
194d
Cleared
Apr 16, 2020
DD Contrast
Dental Direkt GmbH
Dental
115d
Cleared
Jan 31, 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
Qinhuangdao Audental Metal Technology Co., Ltd.
Dental
137d
Cleared
Jan 30, 2020
Noritake Super Porcelain EX-3
Kuraray Noritake Dental, Inc.
Dental
90d
Cleared
Jan 15, 2020
Livento Press, Soprano 10, Soprano
Cendres & Metaux SA
Dental
148d
Cleared
Dec 20, 2019
Non-Sterile Zirconia Block
Fine Advanced Compound Co., Ltd.
Dental
331d
Cleared
Nov 22, 2019
Color Liquid, Vita Liquid
Zirkonzahn Srl
Dental
263d
Cleared
Nov 22, 2019
BruxZir GT (Gum Tissue) Color
Prismatik Dentalcraft, Inc.
Dental
129d
Cleared
Nov 04, 2019
EthanZir Zirconia
Besorah Dental Solutions NZ Limited
Dental
174d
Cleared
Nov 01, 2019
ZMAXX Dental Zirconia Blanks
Zmaxx Bioceramics, LLC
Dental
135d
Cleared
Oct 11, 2019
Razor, Everest, U&C Liquid
U&C International Co., Ltd.
Dental
87d
Cleared
Oct 03, 2019
Vintage Art Universal
Shofu Dental Corporation
Dental
92d
Cleared
Jul 29, 2019
Shaders ZR
Digital Age Dental Lab
Dental
145d
Cleared
May 23, 2019
KATANA Zirconia Block
Kuraray Noritake Dental, Inc.
Dental
90d
Cleared
May 22, 2019
Dental Ceramic
Baot Biological Technology Co., Ltd.
Dental
266d
Cleared
Apr 12, 2019
ArgenZ HT+
The Argen Corporation
Dental
86d
Cleared
Apr 04, 2019
Prettau, ICE, Z-White zirconia blanks
Zirkonzahn Srl
Dental
127d
Cleared
Mar 20, 2019
Jensen Shade Effect Liquids
Jensen Industries, Inc.
Dental
100d