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
97–120 of 480
Cleared Aug 18, 2020
Coloring Liquid
K192723
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 326d
Cleared Jul 21, 2020
VITA LUMEX AC
K193434
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 223d
Cleared Jul 08, 2020
Dental Glass Ceramics Blocks
K192231
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 327d
Cleared Jun 10, 2020
BruxZir Steel
K200131
Prismatik Dentalcraft, Inc.
Dental · 141d
Cleared May 29, 2020
Dental Zirconia Blocks
K192262
De Corematrix Co., Ltd.
Dental · 282d
Cleared May 14, 2020
VITA Ambria
K193436
Vita Zahnfabrik GmbH H Rauter & CO
Dental · 155d
Cleared May 13, 2020
Purzir Dental Zirconia
K193055
3DBiocad
Dental · 194d
Cleared Apr 16, 2020
DD Contrast
K193588
Dental Direkt GmbH
Dental · 115d
Cleared Jan 31, 2020
Unshaded Dental Zirconia and Pre-Shaded Dental Zirconia
K192535
Qinhuangdao Audental Metal Technology Co., Ltd.
Dental · 137d
Cleared Jan 30, 2020
Noritake Super Porcelain EX-3
K193060
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared Jan 15, 2020
Livento Press, Soprano 10, Soprano
K192251
Cendres & Metaux SA
Dental · 148d
Cleared Dec 20, 2019
Non-Sterile Zirconia Block
K190112
Fine Advanced Compound Co., Ltd.
Dental · 331d
Cleared Nov 22, 2019
Color Liquid, Vita Liquid
K190518
Zirkonzahn Srl
Dental · 263d
Cleared Nov 22, 2019
BruxZir GT (Gum Tissue) Color
K191903
Prismatik Dentalcraft, Inc.
Dental · 129d
Cleared Nov 04, 2019
EthanZir Zirconia
K191304
Besorah Dental Solutions NZ Limited
Dental · 174d
Cleared Nov 01, 2019
ZMAXX Dental Zirconia Blanks
K191631
Zmaxx Bioceramics, LLC
Dental · 135d
Cleared Oct 11, 2019
Razor, Everest, U&C Liquid
K191902
U&C International Co., Ltd.
Dental · 87d
Cleared Oct 03, 2019
Vintage Art Universal
K191794
Shofu Dental Corporation
Dental · 92d
Cleared Jul 29, 2019
Shaders ZR
K190569
Digital Age Dental Lab
Dental · 145d
Cleared May 23, 2019
KATANA Zirconia Block
K190436
Kuraray Noritake Dental, Inc.
Dental · 90d
Cleared May 22, 2019
Dental Ceramic
K182350
Baot Biological Technology Co., Ltd.
Dental · 266d
Cleared Apr 12, 2019
ArgenZ HT+
K190079
The Argen Corporation
Dental · 86d
Cleared Apr 04, 2019
Prettau, ICE, Z-White zirconia blanks
K183304
Zirkonzahn Srl
Dental · 127d
Cleared Mar 20, 2019
Jensen Shade Effect Liquids
K183408
Jensen Industries, Inc.
Dental · 100d