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 Prismatik Dentalcraft, Inc., Aidite (Qinhuangdao) Technology Co., Ltd. and Kuraray Noritake Dental, Inc..

479
Total
479
Cleared
111d
Avg days
1977
Since
479 devices
25–48 of 479
Cleared Sep 18, 2024
Copra Supreme
K233064
Whitepeaks Dental Solutions GmbH
Dental · 358d
Cleared Sep 06, 2024
DD Hybridlayer (multicolored zirconia)
K241579
Dental Direkt GmbH
Dental · 95d
Cleared Aug 30, 2024
Kingcera Dental Zirconia Blank
K241602
Hunan Qinghao Puzhong Technology Co., Ltd.
Dental · 87d
Cleared Aug 28, 2024
Cercon® yo ML
K241557
Dentsply Sirona
Dental · 89d
Cleared Jul 12, 2024
Dental Glass Ceramics Blocks (HT,LT,ST)
K241715
Aidite (Qinhuangdao) Technology Co., Ltd.
Dental · 28d
Cleared Jul 09, 2024
Zirconia Block
K241316
Hunan Hualian Special Ceramics Co., Ltd.
Dental · 60d
Cleared Jun 24, 2024
Copran Zri
K232952
Whitepeaks Dental Solutions GmbH
Dental · 277d
Cleared Jun 21, 2024
rainbow Paste Stain SE
K233885
Genoss Co., Ltd.
Dental · 196d
Cleared Jun 20, 2024
Copra Smile, Copra Supreme Hyperion
K233158
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)
K240672
Zhejiang Zahndent Biotechnology Co., Ltd.
Dental · 88d
Cleared May 31, 2024
Dental Zirconia Block (Models HT-plus, ST, SHT, UT, 3D-Pro)
K240912
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)
K240772
Hunan Ceramaster Material Technology Co., Ltd.
Dental · 60d
Cleared May 01, 2024
BruxZir® Esthetic
K240882
Prismatik Dentalcraft, Inc.
Dental · 30d
Cleared Apr 12, 2024
UltraThineer Zirconia Slurry (5Y-B)
K240419
Boston Micro Fabrication
Dental · 59d
Cleared Mar 20, 2024
BruxZir® Radiant
K240574
Prismatik Dentalcraft, Inc.
Dental · 19d
Cleared Mar 19, 2024
Pre-Sintered Zirconia Coloring Liquid
K232682
Chengdu Besmile Medical Technology Co., Ltd.
Dental · 200d
Cleared Feb 27, 2024
Obsidian® NOW
K234014
Prismatik Dentalcraft, Inc.
Dental · 70d
Cleared Feb 23, 2024
rainbowTM Multi-Layer Block / bright 3-Layer / bright Mono
K232174
Genoss Co., Ltd.
Dental · 217d
Cleared Jan 23, 2024
Dental Glass Ceramics
K232673
Chengdu Besmile Medical Technology Co., Ltd.
Dental · 144d
Cleared Jan 23, 2024
Dental Porcelain Powder
K232676
Chengdu Besmile Medical Technology Co., Ltd.
Dental · 144d
Cleared Jan 12, 2024
Zirconia Block
K233125
Hangzhou Ivista Medical Devices Co., Ltd.
Dental · 107d
Cleared Sep 07, 2023
Gradual Dental Zirconia Blank
K231687
Liaoning Upcera Co., Ltd.
Dental · 90d
Cleared Jun 09, 2023
BruxZir™ TintEFX Coloring Liquid
K231347
Prismatik Dentalcraft, Inc.
Dental · 31d
Cleared May 16, 2023
BruxZir™ Incisal Coloring Liquid
K230262
Prismatik Dentalcraft, Inc.
Dental · 105d