ELWClass II

Material, Impression

21 CFR 872.3660 / Dental

ELW is the FDA product code for Material, Impression, a class II device type, regulated under 21 CFR 872.3660. As of 2026-09-10, FDA records hold 402 510(k) clearances under this code, the most recent dated 2026-03-19, and 14 recalls.

Classification record

Product code: ELW
Device name: Material, Impression
Regulation: 21 CFR 872.3660
Device class: Class II
Review panel: Dental
Submission type: 510(k)
Implant: No
Life sustaining or supporting: No
GMP exempt: No
Third party review eligible: Yes
Ingested clearances: 404
Ingested recalls: 14

Clearances, product code ELW

By decision year

404 clearances under product code ELW with a decision year between 1976 and 2026, 1994 the highest year at 22.

Show the numbers

510(k) clearances under FDA product code ELW by decision year
Year	Clearances
1976	9
1977	4
1978	5
1979	3
1980	9
1981	12
1982	5
1983	2
1984	4
1985	5
1986	12
1987	4
1988	3
1989	9
1990	11
1991	8
1992	5
1993	5
1994	22
1995	19
1996	14
1997	17
1998	10
1999	10
2000	16
2001	18
2002	11
2003	10
2004	7
2005	17
2006	7
2007	7
2008	11
2009	7
2010	5
2011	9
2012	7
2013	5
2014	11
2015	8
2016	7
2017	3
2018	5
2019	2
2020	4
2021	3
2022	7
2023	2
2024	3
2025	2
2026	3

Applicants with the most clearances

Product code ELW

Applicants holding the most 510(k) clearances under product code ELW
Applicant	Clearances
Kulzer GmbH	23
Zhermack S.p.A.	19
Dentsply Intl.	18
Sybron Dental Specialties, Inc.	18
Cavex Holland B.V.	16
GC America Inc.	15
Zhermack Dental Production	11
Crown Delta Corp.	10
Espe Dental AG	10
Harry J. Bosworth Co.	10

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 141 companies shown, in name order