LBH · Class II · 21 CFR 872.3260

FDA Product Code LBH: Varnish, Cavity

Leading manufacturers include Dentsply Intl., 3M Company and Dr. Collins, Inc..

137
Total
137
Cleared
126d
Avg days
1976
Since
Growing category - 9 submissions in the last 2 years vs 4 in the prior period
Review times increasing: avg 164d recently vs 124d historically

FDA 510(k) Cleared Varnish, Cavity Devices (Product Code LBH)

137 devices
1–24 of 137
Cleared May 01, 2026
VOCO Profluorid Varnish + BioMin
K252073
Voco GmbH
Dental · 303d
Cleared Apr 30, 2026
UltraEZ
K261404
Ultradent Products, Inc.
Dental · 1d
Cleared Mar 18, 2026
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
K260830
Sangi Co, Ltd.
Dental · 5d
Cleared Nov 21, 2025
FluoroDose Varnish
K250714
Centrix, Inc.
Dental · 256d
Cleared May 27, 2025
Rennou™ Varnish (3% / Spearmint)
K243777
Theodent, LLC
Dental · 169d
Cleared Jan 08, 2025
ReminGel
K241489
Inter-Med, Inc.
Dental · 229d
Cleared Jan 02, 2025
CrystLCare™ PRO Biorestorative, Fluoride-Plus
K241568
GreenMark Biomedical, Inc.
Dental · 216d
Cleared Nov 22, 2024
Jasmate® Toothpaste
K242913
Jasberry Healthcare Private Limited
Dental · 59d
Cleared Jul 18, 2024
Papacarie Duo
K233768
Elevate Oral Care
Dental · 237d
Cleared Jun 13, 2024
ProMin Dental Desensitizing Gel
K231060
Belport Company, Inc., Gingi-Pak
Dental · 427d
Cleared Jul 24, 2023
Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Varnish Normal pack berry (14804), Profisil Fluoride Varnish Normal pack unflavored (14806), Profisil Fluoride Varnish Sample pack (14800)
K230333
Kettenbach GmbH & Co. KG
Dental · 167d
Cleared May 25, 2023
Dental Desensitizer
K222891
Guangzhou Beogene Biotech Co., Ltd.
Dental · 244d
Cleared May 10, 2023
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
K231338
3M Espe Dental Products
Dental · 2d
Cleared Feb 16, 2022
Apapro Desensitizer
K220419
Sangi Co, Ltd.
Dental · 2d
Cleared Nov 06, 2020
BioMin Restore Plus
K200077
Dr. Collins, Inc.
Dental · 297d
Cleared Jun 25, 2020
FiteBac Antimicrobial Cavity Cleanser
K200614
Largent Health, LLC
Dental · 108d
Cleared Feb 18, 2020
DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizing Varnish-Spearmint Flavor, DFV Desensitizing Varnish-Chocolate Flavor, DFV Desensitizing Varnish-Marshmallow Flavor
K192381
Scientific Pharmaceuticals
Dental · 172d
Cleared Feb 11, 2020
Cervitec F
K191453
Ivoclar Vivadent, AG
Dental · 256d
Cleared Jan 23, 2020
FiteBac Cavity Cleanser
K190271
Largent Health, LLC
Dental · 349d
Cleared Nov 18, 2019
FluoroCal
K182917
Bisco, Inc.
Dental · 395d
Cleared Jun 13, 2019
Restore Toothpaste
K181965
Dr. Collins, Inc.
Dental · 325d
Cleared Sep 18, 2015
Clinpro Varnish
K151302
3M Company
Dental · 126d
Cleared Apr 15, 2009
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
K090519
3M Company
Dental · 48d
Cleared Sep 15, 2003
FLUORIDE VARNISH
K031932
Dentsply Intl.
Dental · 84d

About Product Code LBH - Regulatory Context

510(k) Submission Activity

137 total 510(k) submissions under product code LBH since 1976, with 137 receiving FDA clearance (average review time: 126 days).

Submission volume has increased in recent years - 9 submissions in the last 24 months compared to 4 in the prior period - suggesting growing market activity in this device classification.

FDA 510(k) Review Time - LBH Product Code

Recent submissions under LBH have taken an average of 164 days to reach a decision - up from 124 days historically. Manufacturers should account for longer review timelines in current project planning.

LBH devices are reviewed by the Dental panel. Browse all Dental devices →