FDA Product Code EMA: Cement, Dental
FDA product code EMA covers dental cements used for the luting of restorations and the cementation of crowns, bridges, and orthodontic appliances.
These materials form a stable bond between tooth structure and restorative materials, sealing the margin against bacterial ingress and providing mechanical retention. Available formulations include resin, glass ionomer, zinc phosphate, and resin-modified glass ionomer cements.
EMA devices are Class II medical devices, regulated under 21 CFR 872.3275 and reviewed by the FDA Dental panel.
Leading manufacturers include Shofu Dental Corporation, Voco GmbH and Rizhao Huge Biomaterials Company, Ltd..
FDA 510(k) Cleared Cement, Dental Devices (Product Code EMA)
About Product Code EMA - Regulatory Context
510(k) Submission Activity
504 total 510(k) submissions under product code EMA since 1976, with 504 receiving FDA clearance (average review time: 98 days).
Submission volume has increased in recent years - 14 submissions in the last 24 months compared to 9 in the prior period - suggesting growing market activity in this device classification.
FDA Review Time
Recent submissions under EMA have taken an average of 119 days to reach a decision - up from 97 days historically. Manufacturers should account for longer review timelines in current project planning.
EMA devices are reviewed by the Dental panel. Browse all Dental devices →