FDA Product Code DZE: Implant, Endosseous, Root-form
Root-form dental implants are the standard of care for replacing missing teeth. FDA product code DZE covers endosseous root-form implants — titanium or zirconia fixtures that are surgically placed into the jawbone to support prosthetic restorations.
These implants osseointegrate with the surrounding bone to provide a stable, long-term foundation for crowns, bridges, and full-arch rehabilitations. They are used by oral surgeons, periodontists, and implantologists.
DZE devices are Class II medical devices, regulated under 21 CFR 872.3640 and reviewed by the FDA Dental panel.
Leading manufacturers include Institut Straumann AG, Megagen Implant Co., Ltd. and Dentis Co., Ltd..
List of Implant, Endosseous, Root-form devices cleared through 510(k)
How to use this database
This page lists all FDA 510(k) submissions for Implant, Endosseous, Root-form devices (product code DZE). 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 →