NHA · Class II · 21 CFR 872.3630

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..

702
Total
702
Cleared
169d
Avg days
1993
Since
702 devices
73–96 of 702
Cleared May 24, 2024
KATANA Zirconia ONE For IMPLANT
K233285
Kuraray Noritake Dental, Inc.
Dental · 238d
Cleared May 15, 2024
BruxZir® NOW SRC
K231940
Prismatik Dentalcraft, Inc.
Dental · 320d
Cleared May 09, 2024
Customized Abutment
K234112
Arum Dentistry Co., Ltd.
Dental · 134d
Cleared May 07, 2024
CEREC Cercon 4D™ Abutment Blocks, CEREC Cercon 4D™ Abutment System
K234018
Dentsply Sirona
Dental · 139d
Cleared May 02, 2024
Neodent Implant System – Custom Abutments
K233857
JJGC Ind?stria e Com?rcio de Materiais Dent?rios S.A.
Dental · 149d
Cleared Apr 30, 2024
Protective Cap
K232528
Neobiotech Co., Ltd.
Dental · 253d
Cleared Apr 24, 2024
DESS Dental Smart Solutions
K240208
Terrats Medical SL
Dental · 90d
Cleared Apr 15, 2024
Medentika Abutment System, Medentika CAD/CAM Abutments, Medentika CAD/CAM TiBases, Medentika Multi-unit Abutments
K223113
Medentika GmbH
Dental · 560d
Cleared Mar 26, 2024
J & P Click Attachments
K231132
J & P Dental Technologies
Dental · 340d
Cleared Mar 25, 2024
LW Implant System – Abutment
K233167
Ossvis Co., Ltd.
Dental · 180d
Cleared Mar 09, 2024
Osteon Precision Milled Suprastructure
K233083
Implant Solutions Pty Ltd (Aka Osteon Medical)
Dental · 165d
Cleared Mar 05, 2024
DGA Abutment
K231210
Modern Dental Laboratory (Dg) Co., Ltd.
Dental · 313d
Cleared Mar 01, 2024
Zfx Abutments
K231915
Zfx GmbH - A Company of Zimvie
Dental · 246d
Cleared Feb 21, 2024
Oneday Implant Abutment
K231753
Oneday Biotech Co., Ltd.
Dental · 251d
Cleared Feb 20, 2024
TS Abutment System
K233194
Osstem Implant Co., Ltd.
Dental · 145d
Cleared Jan 24, 2024
NobelProcera Titanium ASC Abutment, Omnigrip Clinical Screw Titanium
K233208
Nobel Biocare AB
Dental · 118d
Cleared Jan 22, 2024
MegaGen Dental Implant Abutment - Scan Healing Abutment
K233450
Megagen Implant Co., Ltd.
Dental · 94d
Cleared Jan 12, 2024
Ti Link Abutment
K232170
Izenimplant Co., Ltd.
Dental · 175d
Cleared Jan 05, 2024
DESS Dental Smart Solutions
K233316
Terrats Medical SL
Dental · 98d
Cleared Jan 04, 2024
Anthogyr FlexiBase® titanium bases for Axiom® BL
K231072
Anthogyr
Dental · 265d
Cleared Dec 21, 2023
Elos Accurate Customized Abutment
K231307
Elos Medtech Pinol A/S
Dental · 230d
Cleared Dec 20, 2023
INNO SLA Submerged Hybrid Ti-Base System
K231411
Cowellmedi Co., Ltd.
Dental · 218d
Cleared Dec 19, 2023
Angled Abutment
K232560
Arum Dentistry Co., Ltd.
Dental · 118d
Cleared Dec 08, 2023
BTI Interna Prosthetic Components
K232750
B.T.I. Biotechnology Institute, Sl.
Dental · 91d