EBFClass II

Material, Tooth Shade, Resin

21 CFR 872.3690 / Dental

EBF is the FDA product code for Material, Tooth Shade, Resin, a class II device type, regulated under 21 CFR 872.3690. As of 2026-09-10, FDA records hold 934 510(k) clearances under this code, the most recent dated 2026-07-01, and 71 recalls.

Classification record

Product code: EBF
Device name: Material, Tooth Shade, Resin
Regulation: 21 CFR 872.3690
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: 937
Ingested recalls: 71

Clearances, product code EBF

By decision year

937 clearances under product code EBF with a decision year between 1976 and 2026, 1998 the highest year at 39.

Show the numbers

510(k) clearances under FDA product code EBF by decision year
Year	Clearances
1976	4
1977	9
1978	9
1979	12
1980	12
1981	18
1982	10
1983	10
1984	22
1985	18
1986	27
1987	26
1988	18
1989	15
1990	37
1991	15
1992	29
1993	25
1994	34
1995	21
1996	26
1997	22
1998	39
1999	27
2000	25
2001	35
2002	25
2003	14
2004	14
2005	10
2006	16
2007	19
2008	14
2009	20
2010	19
2011	19
2012	11
2013	13
2014	10
2015	17
2016	20
2017	15
2018	15
2019	17
2020	15
2021	13
2022	17
2023	9
2024	18
2025	15
2026	17

Applicants with the most clearances

Product code EBF

Applicants holding the most 510(k) clearances under product code EBF
Applicant	Clearances
Kulzer GmbH	37
Sybron Dental Specialties, Inc.	35
Voco GmbH	34
Pulpdent Corporation	29
Scientific Pharmaceuticals, Inc.	29
Dentsply Intl.	28
Ivoclar North America, Inc.	28
Shofu Dental Corp.	27
GC America Inc.	23
Kuraray Co.	18

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 196 companies shown, in name order