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
121–144 of 480
Cleared Feb 14, 2019
DD cube ONE ML
K183569
Dental Direkt GmbH
Dental · 55d
Cleared Feb 08, 2019
ArgenZ Liquid Shade, ArgenZ Incisal Effect, ArgenZ Color Modifier, ArgenZ Pontic Reducer
K182833
The Argen Corporation
Dental · 122d
Cleared Jan 25, 2019
GenesisZr™ 4Y Zirconia
K182642
United Dental Resources Corporation
Dental · 123d
Cleared Dec 18, 2018
VINTAGE PRO
K181496
Shofu Dental Corporation
Dental · 194d
Cleared Dec 13, 2018
Erran Dental Zirconia
K182068
Hangzhou Erran Technology Co., Ltd.
Dental · 134d
Cleared Nov 29, 2018
Ceramic Denture Zirconia Ceramics Block
K181816
Qinhuangdao Silide Ceramic Technology Co., Ltd.
Dental · 143d
Cleared Nov 15, 2018
K2 Zirkon Blank white classic
K173971
Yeti Dentalprodukte GmbH
Dental · 321d
Cleared Oct 31, 2018
LUXEN Zr, LUXEN Smile
K171585
Dentalmax Co., Ltd.
Dental · 518d
Cleared Sep 02, 2018
Upcera Glaze Paste, Glaze Powder, and Glaze Liquid
K181167
Liaoning Upcera Co., Ltd.
Dental · 123d
Cleared Aug 23, 2018
Z-CAD smile
K170050
Metoxit AG
Dental · 595d
Cleared Aug 01, 2018
VITA YZ ST and VITA YZ XT
K180703
Vita Zahnfabrik H.Rauter GmbH & Co.
Dental · 135d
Cleared Apr 24, 2018
Crown Dental Zirconia Blank & Crown Dental Zirconia Pre-Shaded Blank
K180252
Crown Porcelain Dental Technology Co., Ltd.
Dental · 84d
Cleared Mar 08, 2018
DMAX Coloring Liquid
K173769
Dmax Co., Ltd.
Dental · 87d
Cleared Nov 14, 2017
n!ce for Planmill
K173410
Institut Straumann AG
Dental · 13d
Cleared Mar 02, 2017
n!ce Glass Ceramic Blocks for Amann Girrbach
K170420
Institut Straumann AG
Dental · 17d
Cleared Feb 22, 2013
IRIS - HIGH STRENGTH GLASS CERAMIC
K123615
Dentsply Intl.
Dental · 91d
Cleared Jan 26, 2007
CARRARA VOLUMIA
K070019
Dentsply Intl.
Dental · 23d
Cleared Jun 24, 2005
MODIFICATION TO: CERCON BASE
K051462
Dentsply Intl.
Dental · 21d
Cleared Dec 22, 2004
DUCERA ALLCERAM
K043247
Dentsply Intl.
Dental · 29d
Cleared Jul 30, 2004
CERCON CERAM EXPRESS CERAMIC SYSTEM
K041707
Dentsply Intl.
Dental · 37d
Cleared Mar 30, 2004
CARRARA INTERACTION CERAMIC SYSTEM
K040635
Dentsply Intl.
Dental · 20d
Cleared Mar 18, 2004
DUCERAM PLUS CERAMIC SYSTEM
K040420
Dentsply Intl.
Dental · 29d
Cleared Mar 18, 2004
DUCERAGOLD PORCELAINS
K040421
Dentsply Intl.
Dental · 29d
Cleared Jan 23, 2004
CARRARA PRESS SYSTEM
K033667
Dentsply Intl.
Dental · 63d