LBHClass II

Varnish, Cavity

21 CFR 872.3260 / Dental

LBH is the FDA product code for Varnish, Cavity, a class II device type, regulated under 21 CFR 872.3260. As of 2026-09-10, FDA records hold 138 510(k) clearances under this code, the most recent dated 2026-06-11, and 9 recalls.

Classification record

Product code: LBH
Device name: Varnish, Cavity
Regulation: 21 CFR 872.3260
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: 139
Ingested recalls: 9

Clearances, product code LBH

By decision year

139 clearances under product code LBH with a decision year between 1976 and 2026, 2007 the highest year at 8.

Show the numbers

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

Applicants with the most clearances

Product code LBH

Applicants holding the most 510(k) clearances under product code LBH
Applicant	Clearances
Pulpdent Corporation	10
Scientific Pharmaceuticals, Inc.	9
Ultradent Products Inc.	9
Dentsply Intl.	6
Novamin Technology, Inc.	6
Centrix, Inc.	5
Ivoclar Vivadent, Inc.	4
Cao Group, Inc.	3
Dental Dimensions Supply Co.	3
Voco GmbH	3

Companies listing this code with FDA

Companies whose registered establishments list this code

12 of 83 companies shown, in name order