DZEClass II

Implant, Endosseous, Root-Form

21 CFR 872.3640 / Dental

DZE is the FDA product code for Implant, Endosseous, Root-Form, a class II device type, regulated under 21 CFR 872.3640. As of 2026-09-10, FDA records hold 1,548 510(k) clearances under this code, the most recent dated 2026-08-19, and 211 recalls.

Classification record

Product code: DZE
Device name: Implant, Endosseous, Root-Form
Regulation: 21 CFR 872.3640
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: 1,549
Ingested recalls: 212

Clearances, product code DZE

By decision year

1,549 clearances under product code DZE with a decision year between 1976 and 2026, 1995 the highest year at 103.

Show the numbers

510(k) clearances under FDA product code DZE by decision year
Year	Clearances
1976	1
1977	3
1978	2
1979	2
1980	3
1981	3
1982	5
1983	1
1984	6
1985	5
1986	14
1987	13
1988	14
1989	17
1990	37
1991	44
1992	23
1993	35
1994	51
1995	103
1996	67
1997	43
1998	33
1999	27
2000	22
2001	41
2002	39
2003	32
2004	42
2005	32
2006	42
2007	43
2008	61
2009	41
2010	34
2011	26
2012	39
2013	42
2014	36
2015	36
2016	40
2017	48
2018	41
2019	31
2020	41
2021	34
2022	34
2023	35
2024	40
2025	31
2026	14

Applicants with the most clearances

Product code DZE

Applicants holding the most 510(k) clearances under product code DZE
Applicant	Clearances
ZimVie US Corp LLC	67
Straumann USA, LLC	67
Nobelpharma USA, Inc.	51
Steri-Oss, Inc.	40
Minimatic Implant Technology	34
Implant Center of the Palm Beaches	32
Nobel Biocare AB	31
OSSTEM Implant Co., Ltd.	27
BioHorizons Implant Systems Inc	26
Core-Vent Corp.	24

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 300 companies shown, in name order