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 Institut Straumann AG, Nobel Biocare AB and Terrats Medical SL.
713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
Cleared
Sep 13, 2024
Elos Accurate® Hybrid Base™
Elos Medtech Pinol A/S
Dental
91d
Cleared
Aug 26, 2024
DESS Dental Smart Solutions
Terrats Medical SL
Dental
138d
Cleared
Aug 20, 2024
TDS (TECHWIN DENTAL SYSTEM)
Techwin Co., Ltd.
Dental
417d
Cleared
Jul 30, 2024
SmartShape™ Healing Abutment
BioHorizons Implant Systems, Inc.
Dental
158d
Cleared
Jul 25, 2024
s-Clean ScanHealing Abutment
Dentis Co., Ltd.
Dental
98d
Cleared
Jul 15, 2024
BellaTek Bars
Biomet 3i, LLC
Dental
90d
Cleared
Jul 12, 2024
Inclusive® Titanium Abutments compatible with: Keystone® Dental PrimaConnex®, Neodent® GM, Straumann® BLX, Implant Direct® Legacy®, Implant Direct® InterActive®, Implant Direct® RePlant® Implant Systems
Prismatik Dentalcraft, Inc.
Dental
164d
Cleared
Jun 07, 2024
IPD Dental Implant Abutments
Implant Protesis Dental 2004, S.L.
Dental
99d
Cleared
Jun 05, 2024
Ti-Base & Master Fix
Arum Dentistry Co., Ltd.
Dental
93d
Cleared
Jun 03, 2024
LOCATOR Angled Abutment (Various)
Zest Anchors, LLC
Dental
208d
Cleared
May 29, 2024
EK Digital Abutments
Hiossen, Inc.
Dental
240d
Cleared
May 24, 2024
KATANA Zirconia ONE For IMPLANT
Kuraray Noritake Dental, Inc.
Dental
238d
Cleared
May 15, 2024
BruxZir® NOW SRC
Prismatik Dentalcraft, Inc.
Dental
320d
Cleared
May 09, 2024
Customized Abutment
Arum Dentistry Co., Ltd.
Dental
134d
Cleared
May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
Dentsply Sirona
Dental
139d
Cleared
May 02, 2024
Neodent Implant System – Custom Abutments
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental
149d
Cleared
Apr 30, 2024
Protective Cap
Neobiotech Co., Ltd.
Dental
253d
Cleared
Apr 24, 2024
DESS Dental Smart Solutions
Terrats Medical SL
Dental
90d
Cleared
Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
Medentika GmbH
Dental
560d
Cleared
Mar 26, 2024
J & P Click Attachments
J & P Dental Technologies
Dental
340d
Cleared
Mar 25, 2024
LW Implant System – Abutment
Ossvis Co., Ltd.
Dental
180d
Cleared
Mar 09, 2024
Osteon Precision Milled Suprastructure
Implant Solutions Pty Ltd (Aka Osteon Medical)
Dental
165d
Cleared
Mar 05, 2024
DGA Abutment
Modern Dental Laboratory (Dg) Co., Ltd.
Dental
313d
Cleared
Mar 01, 2024
Zfx Abutments
Zfx GmbH - A Company of Zimvie
Dental
246d