NHAClass II

Abutment, Implant, Dental, Endosseous

21 CFR 872.3630 / Dental

NHA is the FDA product code for Abutment, Implant, Dental, Endosseous, a class II device type, regulated under 21 CFR 872.3630. FDA's definition for this code reads: "To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation". As of 2026-09-10, FDA records hold 713 510(k) clearances under this code, the most recent dated 2026-08-06, and 225 recalls.

Classification record

Product code: NHA
Device name: Abutment, Implant, Dental, Endosseous
FDA definition: To be used in conjunction with an endosseous dental implant fixture to aid in prosthetic rehabilitation.
Regulation: 21 CFR 872.3630
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: Yes
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: No
Ingested clearances: 715
Ingested recalls: 225

Clearances, product code NHA

By decision year

715 clearances under product code NHA with a decision year between 1993 and 2026, 2023 the highest year at 51.

Show the numbers

510(k) clearances under FDA product code NHA by decision year
Year	Clearances
1993	3
1996	2
1997	3
1998	1
2002	5
2003	6
2004	13
2005	15
2006	31
2007	38
2008	31
2009	30
2010	19
2011	31
2012	25
2013	22
2014	27
2015	29
2016	38
2017	31
2018	31
2019	28
2020	38
2021	29
2022	33
2023	51
2024	43
2025	40
2026	22

Applicants with the most clearances

Product code NHA

Applicants holding the most 510(k) clearances under product code NHA
Applicant	Clearances
Straumann USA, LLC	82
ZimVie US Corp LLC	47
Nobel Biocare AB	43
Dentsply Sirona Inc	23
Terrats Medical, S.L.	21
Prismatik Dentalcraft, Inc.	19
OSSTEM Implant Co., Ltd.	18
Atlantis Components, Inc.	17
Astra Tech, Inc.	16
Thommen Medical AG	16

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 348 companies shown, in name order