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
Feb 14, 2019
DD cube ONE ML
Dental Direkt GmbH
Dental
55d
Cleared
Feb 08, 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
The Argen Corporation
Dental
122d
Cleared
Jan 25, 2019
GenesisZr™ 4Y Zirconia
United Dental Resources Corporation
Dental
123d
Cleared
Dec 18, 2018
VINTAGE PRO
Shofu Dental Corporation
Dental
194d
Cleared
Dec 13, 2018
Erran Dental Zirconia
Hangzhou Erran Technology Co., Ltd.
Dental
134d
Cleared
Nov 29, 2018
Ceramic Denture Zirconia Ceramics Block
Qinhuangdao Silide Ceramic Technology Co., Ltd.
Dental
143d
Cleared
Nov 15, 2018
K2 Zirkon Blank white classic
Yeti Dentalprodukte GmbH
Dental
321d
Cleared
Oct 31, 2018
LUXEN Zr, LUXEN Smile
Dentalmax Co., Ltd.
Dental
518d
Cleared
Sep 02, 2018
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
Liaoning Upcera Co., Ltd.
Dental
123d
Cleared
Aug 23, 2018
Z-CAD smile
Metoxit AG
Dental
595d
Cleared
Aug 01, 2018
VITA YZ ST and VITA YZ XT
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental
135d
Cleared
Apr 24, 2018
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
Crown Porcelain Dental Technology Co., Ltd.
Dental
84d
Cleared
Mar 08, 2018
DMAX Coloring Liquid
Dmax Co., Ltd.
Dental
87d
Cleared
Nov 14, 2017
n!ce for Planmill
Institut Straumann AG
Dental
13d
Cleared
Mar 02, 2017
n!ce Glass Ceramic Blocks for Amann Girrbach
Institut Straumann AG
Dental
17d
Cleared
Feb 22, 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
Dentsply Intl.
Dental
91d
Cleared
Jan 26, 2007
CARRARA VOLUMIA
Dentsply Intl.
Dental
23d
Cleared
Jun 24, 2005
MODIFICATION TO: CERCON BASE
Dentsply Intl.
Dental
21d
Cleared
Dec 22, 2004
DUCERA ALLCERAM
Dentsply Intl.
Dental
29d
Cleared
Jul 30, 2004
CERCON CERAM EXPRESS CERAMIC SYSTEM
Dentsply Intl.
Dental
37d
Cleared
Mar 30, 2004
CARRARA INTERACTION CERAMIC SYSTEM
Dentsply Intl.
Dental
20d
Cleared
Mar 18, 2004
DUCERAM PLUS CERAMIC SYSTEM
Dentsply Intl.
Dental
29d
Cleared
Mar 18, 2004
DUCERAGOLD PORCELAINS
Dentsply Intl.
Dental
29d
Cleared
Jan 23, 2004
CARRARA PRESS SYSTEM
Dentsply Intl.
Dental
63d