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..
FDA 510(k) Cleared Powder, Porcelain Devices (Product Code EIH)
About Product Code EIH - Regulatory Context
510(k) Submission Activity
480 total 510(k) submissions under product code EIH since 1977, with 480 receiving FDA clearance (average review time: 111 days).
Submission volume has declined in recent years - 31 submissions in the last 24 months compared to 41 in the prior period.
FDA 510(k) Review Time - EIH Product Code
Recent submissions under EIH have taken an average of 90 days to reach a decision - down from 113 days historically, suggesting improved FDA processing for this classification.
EIH devices are reviewed by the Dental panel. Browse all Dental devices →