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..
FDA 510(k) Cleared Powder, Porcelain Devices (Product Code EIH)
About Product Code EIH - Regulatory Context
510(k) Submission Activity
479 total 510(k) submissions under product code EIH since 1977, with 479 receiving FDA clearance (average review time: 111 days).
Submission volume has remained relatively stable over the observed period, with 36 submissions in the last 24 months.
FDA Review Time
FDA review times for EIH submissions have been consistent, averaging 97 days recently vs 112 days historically.
EIH devices are reviewed by the Dental panel. Browse all Dental devices →