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
49–72 of 480
Cleared Sep 07, 2023
Gradual Dental Zirconia Blank
K231687
Liaoning Upcera Co., Ltd.
Dental · 90d
Cleared Jul 03, 2023
Dental Lithium Disilicate Glass-Ceramic
K230487
Fuzhou Rick Brown Biomaterials Co., Ltd.
Dental · 130d
Cleared Jun 30, 2023
Easy On Universal Glaze & Stain
K231264
Doctus Global
Dental · 59d
Cleared Jun 20, 2023
Perfit CL
K223029
Vatech Mcis Co., Ltd.
Dental · 264d
Cleared Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
K231347
Prismatik Dentalcraft, Inc.
Dental · 31d
Cleared Jun 02, 2023
Harvest Conceal ZR Block Out
K222961
Harvest Dental Products, LLC
Dental · 248d
Cleared May 25, 2023
Soreal Press, Soreal CAD
K230259
Shenzhen Up3D Technology Co., Ltd.
Dental · 114d
Cleared May 16, 2023
BruxZir™ Incisal Coloring Liquid
K230262
Prismatik Dentalcraft, Inc.
Dental · 105d
Cleared Mar 31, 2023
Topzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K230003
Topzir Biotech Co., Ltd.
Dental · 87d
Cleared Mar 27, 2023
XT Stain/Glaze
K223192
Shenzhen Xiangtong Co., Ltd.
Dental · 165d
Cleared Feb 27, 2023
Non-Sterile Zirconia Block (ARENA Star, Mont Blanc)
K223253
Arum Dentistry Co., Ltd.
Dental · 129d
Cleared Feb 10, 2023
Glass Ceramics
K222513
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 175d
Cleared Feb 10, 2023
Glass Ceramic
K223194
Shenzhen Xiangtong Co., Ltd.
Dental · 120d
Cleared Dec 14, 2022
ICE Ceramics, ICE Stains, Fresco
K213722
Zirkonzahn Srl
Dental · 383d
Cleared Dec 06, 2022
Dental Zirconia Ceramic
K222626
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 97d
Cleared Nov 14, 2022
Zirconia Block
K222520
Yilink (Tianjin) Biotechnology Co., Ltd.
Dental · 87d
Cleared Oct 06, 2022
Perfit FS Dental Zirconia Fully Sintered Block
K222686
Vatech Acucera, Inc.
Dental · 30d
Cleared Sep 23, 2022
Esthetic Colorant
K220369
Kuraray Noritake Dental, Inc.
Dental · 227d
Cleared Aug 02, 2022
BruxZir NOW
K220816
Prismatik Dentalcraft, Inc.
Dental · 134d
Cleared Jul 29, 2022
Vsmilehappyzir Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221242
Hunan Vsmile Biotechnology Co., Ltd.
Dental · 88d
Cleared Jul 14, 2022
KDF Zirconia Disc
K221429
Denken-Highdental Co., Ltd.
Dental · 59d
Cleared Jul 08, 2022
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank
K221051
Changsha Honchon Technology Co., Ltd.
Dental · 88d
Cleared Jun 29, 2022
Coloring Liquid
K220017
Dongguan Xiangtong Co., Ltd.
Dental · 175d
Cleared Jun 29, 2022
BruxZir Opaque Coloring Liquid
K220960
Prismatik Dentalcraft, Inc.
Dental · 89d