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, Terrats Medical SL and Dentsply Sirona.
706
Total
706
Cleared
169d
Avg days
1993
Since
706 devices
Cleared
Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
Southern Implants (Pty), Ltd.
Dental
124d
Cleared
Jul 14, 2023
Bonafix TiBase
Zentek Medical, LLC
Dental
400d
Cleared
Jul 14, 2023
Neodent Implant System - Zirconia Implant System
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental
368d
Cleared
Jul 11, 2023
Dentis i-Clean System
Dentis Co., Ltd.
Dental
158d
Cleared
Jun 20, 2023
SMARTbase Abutment System
Implant Direct Sybron Manufacturing, LLC
Dental
209d
Cleared
May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
Dentis Co., Ltd.
Dental
115d
Cleared
May 24, 2023
SIMDA Abutment
Simda Co., Ltd.
Dental
168d
Cleared
May 24, 2023
s-Clean Link Abutment Narrow
Dentis Co., Ltd.
Dental
86d
Cleared
May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
Institut Straumann AG
Dental
237d
Cleared
May 12, 2023
IU Implant System Abutment
Warantec Co., Ltd.
Dental
311d
Cleared
May 03, 2023
Dentis I-FIX Abutment
Dentis Co., Ltd.
Dental
98d
Cleared
Apr 28, 2023
ET Abutment System
Hiossen, Inc.
Dental
240d
Cleared
Apr 28, 2023
Customized Abutment
Arum Dentistry Co., Ltd.
Dental
144d
Cleared
Apr 28, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
Nobel Biocare AB
Dental
141d
Cleared
Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
Dental Direkt GmbH
Dental
89d
Cleared
Apr 24, 2023
Klockner Abutments
SOADCO, S.L.
Dental
101d
Cleared
Apr 17, 2023
TIB Abutments
Southern Implants (Pty), Ltd.
Dental
244d
Cleared
Apr 13, 2023
DESS Dental Smart Solutions
Terrats Medical SL
Dental
85d
Cleared
Apr 06, 2023
S.I.N. Dental Implant System
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental
86d
Cleared
Mar 23, 2023
Implant-One Multi-Unit Abutment
Implant Logistics, Inc.
Dental
598d
Cleared
Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
Dentsply Sirona, Inc.
Dental
310d
Cleared
Mar 09, 2023
DESS Dental Smart Solutions
Terrats Medical SL
Dental
308d
Cleared
Feb 07, 2023
SAVE GBR
Dentis Co., Ltd.
Dental
176d
Cleared
Feb 03, 2023
Luna Dental Implant System
Shinhung Mst Co., Ltd.
Dental
87d