ELCClass II

Scaler, Ultrasonic

21 CFR 872.4850 / Dental

ELC is the FDA product code for Scaler, Ultrasonic, a class II device type, regulated under 21 CFR 872.4850. As of 2026-09-10, FDA records hold 195 510(k) clearances under this code, the most recent dated 2026-03-10, and 10 recalls.

Classification record

Product code: ELC
Device name: Scaler, Ultrasonic
Regulation: 21 CFR 872.4850
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: 195
Ingested recalls: 10

Clearances, product code ELC

By decision year

195 clearances under product code ELC with a decision year between 1976 and 2026, 2013 the highest year at 13.

Show the numbers

510(k) clearances under FDA product code ELC by decision year
Year	Clearances
1976	4
1977	2
1978	2
1979	4
1980	1
1981	4
1982	3
1983	2
1984	5
1985	2
1986	3
1987	2
1988	2
1989	2
1990	6
1991	1
1992	1
1993	4
1994	2
1995	7
1996	4
1997	5
1998	1
1999	6
2000	8
2001	3
2002	4
2003	5
2004	7
2005	11
2006	7
2007	6
2008	4
2009	4
2010	4
2011	3
2012	1
2013	13
2014	6
2015	5
2016	3
2017	2
2018	1
2019	4
2020	1
2021	3
2022	2
2023	5
2024	4
2025	2
2026	2

Applicants with the most clearances

Product code ELC

Applicants holding the most 510(k) clearances under product code ELC
Applicant	Clearances
E.M.S. - Electro Medical Systems SA	14
Dentsply Intl.	13
Bonart Co. Ltd.	7
Litton Dental Products	7
Nakanishi Inc.	7
Satelec-Acteon Group	7
Sonendo Inc	7
Satelec	6
Dentsply International, Inc.	5
HU-Friedy Mfg. Co. LLC	5

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 104 companies shown, in name order