FDA Product Code NHA: Abutment, Implant, Dental, Endosseous
FDA product code NHA covers dental implant abutments.
These components connect the endosseous implant fixture to the prosthetic restoration — such as a crown, bridge, or denture. They are designed to emerge through the gum tissue and provide a stable foundation for the final prosthesis.
NHA devices are Class II medical devices, regulated under 21 CFR 872.3630 and reviewed by the FDA Dental panel.
Leading manufacturers include Terrats Medical SL, Institut Straumann AG and Dentis Co., Ltd..
FDA 510(k) Cleared Abutment, Implant, Dental, Endosseous Devices (Product Code NHA)
About Product Code NHA - Regulatory Context
510(k) Submission Activity
702 total 510(k) submissions under product code NHA since 1993, with 702 receiving FDA clearance (average review time: 169 days).
Submission volume has declined in recent years - 74 submissions in the last 24 months compared to 93 in the prior period.
FDA Review Time
FDA review times for NHA submissions have been consistent, averaging 177 days recently vs 168 days historically.
NHA devices are reviewed by the Dental panel. Browse all Dental devices →