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 Parkell, Inc..
List of Cement, Dental devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Cement, Dental devices (product code EMA). Click any device to view full submission details, including the decision date, manufacturer information, predicate device, and a link to the official FDA record.
These devices fall under the Dental FDA review panel. Browse all Dental devices →