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 Chengdu Besmile Medical Technology Co., Ltd..

479
Total
479
Cleared
111d
Avg days
1977
Since
479 devices
433–456 of 479
No devices found for this product code.