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
49–72 of 702
Cleared Jan 03, 2025
NobelProcera Zirconia Implant Bridge
K240346
Nobel Biocare AB
Dental · 333d
Cleared Dec 19, 2024
IPD Dental Implant Abutments
K242819
Implant Protesis Dental 2004, S.L.
Dental · 92d
Cleared Dec 17, 2024
ALLONUS Tech Prosthetics
K241616
Allonus Tech Co., Ltd.
Dental · 195d
Cleared Dec 10, 2024
Elos Accurate® Hybrid Base™
K242025
Elos Medtech Pinol A/S
Dental · 152d
Cleared Dec 05, 2024
LW Pre-milled Abutment
K242703
Ossvis Co., Ltd.
Dental · 87d
Cleared Dec 04, 2024
Neodent Implant System
K242686
Jjgc Ind?stria E Com?rcia DE Materiais Dent?rios S.A.
Dental · 89d
Cleared Nov 25, 2024
Customized Abutment
K242245
Arum Dentistry Co., Ltd.
Dental · 117d
Cleared Nov 11, 2024
Straumann® Anatomic Healing Abutments XC (AHA)
K241575
Straumann USA, LLC
Dental · 161d
Cleared Nov 05, 2024
DESS Dental Smart Solutions
K242340
Terrats Medical SL
Dental · 90d
Cleared Oct 21, 2024
Dynamic TiBase
K241170
Talladium Espa?a, SL
Dental · 178d
Cleared Oct 18, 2024
PreXolid CAD/CAM abutments
K240725
Eclectic Co., Ltd.
Dental · 214d
Cleared Oct 09, 2024
TruAbutment DS
K241485
Truabutment, Inc.
Dental · 138d
Cleared Sep 18, 2024
TiGEN Abutment, PMMA Abutment and Scan Healing Abutment
K234142
Megagen Implant Co., Ltd.
Dental · 264d
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