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..
FDA 510(k) Cleared Implant, Endosseous, Root-form Devices (Product Code DZE)
About Product Code DZE - Regulatory Context
510(k) Submission Activity
1542 total 510(k) submissions under product code DZE since 1976, with 1542 receiving FDA clearance (average review time: 202 days).
Submission volume has remained relatively stable over the observed period, with 70 submissions in the last 24 months.
FDA Review Time
FDA review times for DZE submissions have been consistent, averaging 205 days recently vs 202 days historically.
DZE devices are reviewed by the Dental panel. Browse all Dental devices →