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 Institut Straumann AG, Nobel Biocare AB and Terrats Medical SL.

713
Total
713
Cleared
169d
Avg days
1993
Since
713 devices
73–96 of 713
Cleared Sep 13, 2024
Elos Accurate® Hybrid Base™
K241722
Elos Medtech Pinol A/S
Dental · 91d
Cleared Aug 26, 2024
DESS Dental Smart Solutions
K240982
Terrats Medical SL
Dental · 138d
Cleared Aug 20, 2024
TDS (TECHWIN DENTAL SYSTEM)
K231932
Techwin Co., Ltd.
Dental · 417d
Cleared Jul 30, 2024
SmartShape™ Healing Abutment
K240531
BioHorizons Implant Systems, Inc.
Dental · 158d
Cleared Jul 25, 2024
s-Clean ScanHealing Abutment
K241063
Dentis Co., Ltd.
Dental · 98d
Cleared Jul 15, 2024
BellaTek Bars
K241032
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
K240240
Prismatik Dentalcraft, Inc.
Dental · 164d
Cleared Jun 07, 2024
IPD Dental Implant Abutments
K240570
Implant Protesis Dental 2004, S.L.
Dental · 99d
Cleared Jun 05, 2024
Ti-Base & Master Fix
K240603
Arum Dentistry Co., Ltd.
Dental · 93d
Cleared Jun 03, 2024
LOCATOR Angled Abutment (Various)
K233587
Zest Anchors, LLC
Dental · 208d
Cleared May 29, 2024
EK Digital Abutments
K233389
Hiossen, Inc.
Dental · 240d
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