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, Terrats Medical SL and Dentsply Sirona.

706
Total
706
Cleared
169d
Avg days
1993
Since
706 devices
121–144 of 706
Cleared Aug 01, 2023
Angulated Screw Channel (ASC) Solution Abutments & SI-BASE Abutments
K230873
Southern Implants (Pty), Ltd.
Dental · 124d
Cleared Jul 14, 2023
Bonafix TiBase
K221673
Zentek Medical, LLC
Dental · 400d
Cleared Jul 14, 2023
Neodent Implant System - Zirconia Implant System
K222026
Jjgc Industria E Comercio DE Materiais Dentarios S.A.
Dental · 368d
Cleared Jul 11, 2023
Dentis i-Clean System
K230307
Dentis Co., Ltd.
Dental · 158d
Cleared Jun 20, 2023
SMARTbase Abutment System
K223535
Implant Direct Sybron Manufacturing, LLC
Dental · 209d
Cleared May 25, 2023
Dentis s-Clean SQ-SL Narrow Implant System
K230246
Dentis Co., Ltd.
Dental · 115d
Cleared May 24, 2023
SIMDA Abutment
K223663
Simda Co., Ltd.
Dental · 168d
Cleared May 24, 2023
s-Clean Link Abutment Narrow
K230523
Dentis Co., Ltd.
Dental · 86d
Cleared May 15, 2023
Straumann® Variobase® Abutments and Straumann® n!ce® Zirconia discs
K222836
Institut Straumann AG
Dental · 237d
Cleared May 12, 2023
IU Implant System Abutment
K221969
Warantec Co., Ltd.
Dental · 311d
Cleared May 03, 2023
Dentis I-FIX Abutment
K230203
Dentis Co., Ltd.
Dental · 98d
Cleared Apr 28, 2023
ET Abutment System
K222636
Hiossen, Inc.
Dental · 240d
Cleared Apr 28, 2023
Customized Abutment
K223634
Arum Dentistry Co., Ltd.
Dental · 144d
Cleared Apr 28, 2023
Titanium Abutment Blank Nobel Biocare N1 TCC
K223677
Nobel Biocare AB
Dental · 141d
Cleared Apr 25, 2023
DD Solid Connect® CAD/CAM Abutments (further DD Ti-Base 2CUT series)
K230218
Dental Direkt GmbH
Dental · 89d
Cleared Apr 24, 2023
Klockner Abutments
K230103
SOADCO, S.L.
Dental · 101d
Cleared Apr 17, 2023
TIB Abutments
K222469
Southern Implants (Pty), Ltd.
Dental · 244d
Cleared Apr 13, 2023
DESS Dental Smart Solutions
K230143
Terrats Medical SL
Dental · 85d
Cleared Apr 06, 2023
S.I.N. Dental Implant System
K230069
S.I.N. ? Sistema DE Implante Nacional S.A.
Dental · 86d
Cleared Mar 23, 2023
Implant-One Multi-Unit Abutment
K212394
Implant Logistics, Inc.
Dental · 598d
Cleared Mar 22, 2023
CEREC Tessera Abutment Block, CEREC Tessera Abutment System
K221402
Dentsply Sirona, Inc.
Dental · 310d
Cleared Mar 09, 2023
DESS Dental Smart Solutions
K221301
Terrats Medical SL
Dental · 308d
Cleared Feb 07, 2023
SAVE GBR
K222451
Dentis Co., Ltd.
Dental · 176d
Cleared Feb 03, 2023
Luna Dental Implant System
K223395
Shinhung Mst Co., Ltd.
Dental · 87d