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 Prismatik Dentalcraft, Inc., Aidite (Qinhuangdao) Technology Co., Ltd. and Kuraray Noritake Dental, Inc..
479
Total
479
Cleared
111d
Avg days
1977
Since
479 devices
Cleared
Sep 18, 2024
Copra Supreme
Whitepeaks Dental Solutions GmbH
Dental
358d
Cleared
Sep 06, 2024
DD Hybridlayer (multicolored zirconia)
Dental Direkt GmbH
Dental
95d
Cleared
Aug 30, 2024
Kingcera Dental Zirconia Blank
Hunan Qinghao Puzhong Technology Co., Ltd.
Dental
87d
Cleared
Aug 28, 2024
Cercon® yo ML
Dentsply Sirona
Dental
89d
Cleared
Jul 12, 2024
Dental Glass Ceramics Blocks (HT,LT,ST)
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental
28d
Cleared
Jul 09, 2024
Zirconia Block
Hunan Hualian Special Ceramics Co., Ltd.
Dental
60d
Cleared
Jun 24, 2024
Copran Zri
Whitepeaks Dental Solutions GmbH
Dental
277d
Cleared
Jun 21, 2024
rainbow Paste Stain SE
Genoss Co., Ltd.
Dental
196d
Cleared
Jun 20, 2024
Copra Smile, Copra Supreme Hyperion
Whitepeaks Dental Solutions GmbH
Dental
267d
Cleared
Jun 07, 2024
Dental Zirconia Blank & Dental Zirconia Pre-Shaded Blank ( ZD-HT-PLUS, ZD-ST, ZD-SHT, ZD-HT-C, ZD-ST-C, ZD-SHT-C, ZD-UT-C, ZD-ST-ML, ZD-SHT-ML, ZD-UT-ML, ZD-3D-Pro-ML, ZD-4D-Pro-ML)
Zhejiang Zahndent Biotechnology Co., Ltd.
Dental
88d
Cleared
May 31, 2024
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
Anhui Miisen Intelligence Technology Co., Ltd.
Dental
58d
Cleared
May 20, 2024
Dental Zirconia Blank (HT-plus, ST-C, ST-ML, SHT-C, SHT-ML, UT-C, UT-ML, Pro- ML)
Hunan Ceramaster Material Technology Co., Ltd.
Dental
60d
Cleared
May 01, 2024
BruxZir® Esthetic
Prismatik Dentalcraft, Inc.
Dental
30d
Cleared
Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
Boston Micro Fabrication
Dental
59d
Cleared
Mar 20, 2024
BruxZir® Radiant
Prismatik Dentalcraft, Inc.
Dental
19d
Cleared
Mar 19, 2024
Pre-Sintered Zirconia Coloring Liquid
Chengdu Besmile Medical Technology Co., Ltd.
Dental
200d
Cleared
Feb 27, 2024
Obsidian® NOW
Prismatik Dentalcraft, Inc.
Dental
70d
Cleared
Feb 23, 2024
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
Genoss Co., Ltd.
Dental
217d
Cleared
Jan 23, 2024
Dental Glass Ceramics
Chengdu Besmile Medical Technology Co., Ltd.
Dental
144d
Cleared
Jan 23, 2024
Dental Porcelain Powder
Chengdu Besmile Medical Technology Co., Ltd.
Dental
144d
Cleared
Jan 12, 2024
Zirconia Block
Hangzhou Ivista Medical Devices Co., Ltd.
Dental
107d
Cleared
Sep 07, 2023
Gradual Dental Zirconia Blank
Liaoning Upcera Co., Ltd.
Dental
90d
Cleared
Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
31d
Cleared
May 16, 2023
BruxZir™ Incisal Coloring Liquid
Prismatik Dentalcraft, Inc.
Dental
105d