Varnish, Cavity
FDA product code LBH · 131 cleared devices
Class 2
Dental
- Regulation
- 21 CFR 872.3260
- Review panel
- DE
- Implant
- No
- Life sustaining
- No
- Third party review
- Yes
- GMP exempt
- No
- Clearance span
- 1976-09-27 – 2026-09-03
LBH
2026-09-03
LBH
2026-06-11
Fluoride Varnish (Type A,Type C)
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LBH
2026-05-01
VOCO Profluorid Varnish + BioMin
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LBH
2026-04-30
UltraEZ
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LBH
2026-03-18
APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)
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LBH
2025-11-21
FluoroDose Varnish
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LBH
2025-05-27
Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum)
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LBH
2025-01-08
ReminGel
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LBH
2025-01-02
CrystLCare™ PRO Biorestorative, Fluoride-Plus
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LBH
2024-11-22
Jasmate® Toothpaste
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LBH
2024-07-18
Papacarie Duo
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LBH
2024-06-13
ProMin Dental Desensitizing Gel
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LBH
2023-07-24
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)
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LBH
2023-05-25
Dental Desensitizer
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LBH
2023-05-10
3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment
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LBH
2022-02-16
Apapro Desensitizer
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LBH
2020-11-06
BioMin Restore Plus
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LBH
2020-06-25
FiteBac Antimicrobial Cavity Cleanser
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LBH
2020-02-18
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
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LBH
2020-02-11
Cervitec F
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LBH
2020-01-23
FiteBac Cavity Cleanser
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LBH
2019-11-18
FluoroCal
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LBH
2019-06-13
Restore Toothpaste
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LBH
2016-12-02
V-varnish Premium
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LBH
2016-05-20
Oral-B 5% Sodium Fluoride Varnish
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LBH
2013-11-01
ENAMELAST
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LBH
2013-09-18
ALPHA-PRO WHITE VARNISH
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LBH
2013-08-27
SMARTCOAT 2.5% NAF VARNISH
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LBH
2013-06-03
SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED)
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LBH
2013-04-26
PRG BARRIER COAT
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LBH
2013-01-14
REMESENSE FOR SENSITIVE TEETH
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LBH
2012-10-15
CAVITY VARNISH
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LBH
2012-07-25
SENZZZZZ AWAY
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LBH
2012-03-07
SUPER SEAL TOOTH DESENSITIZER
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LBH
2012-01-23
PCXX VARNISH
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LBH
2011-12-09
ACTIV VARNISH
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LBH
2011-09-13
COLGATE DESENSITIZING DENTAL CREAM
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LBH
2011-01-06
NUPRO MODEL 13016901
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LBH
2010-12-22
MI VARNISH
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LBH
2010-10-21
TOKUYAMA SHIELD FORCE
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LBH
2010-09-23
ASCENT F-COAT MODEL: 006-00097
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LBH
2010-05-12
PULPDENT COPAL VARNISH WITH FLUORIDE
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LBH
2010-03-10
PULPDENT FLUORIDE VARNISH
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LBH
2010-03-10
VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH
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LBH
2010-03-05
GLUMA DESENSITIZER POWER GEL
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LBH
2009-04-15
VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247
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LBH
2009-03-19
REMESENSE
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LBH
2009-03-16
FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH
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LBH
2009-01-12
VOCO PROFLUORID L
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LBH
2008-10-29
DURASHIELD PLUS
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LBH
2008-10-02
ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT
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LBH
2008-07-24
VOCO PROFLUORID VARNISH
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LBH
2008-03-27
ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH
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LBH
2008-02-29
THE PROXIVENT KIT
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LBH
2008-02-08
FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505
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LBH
2007-12-19
DENTIN DESENSITIZER AGENT
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LBH
2007-10-03
SULTAN TOOTH ROOT DESENSITIZER
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LBH
2007-09-21
CERVITEC PLUS
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LBH
2007-06-12
ULTRAEZ DESENSITIZING GEL
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LBH
2007-05-25
ASCENT DENTAL CLEANSER
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LBH
2007-05-18
PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN
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LBH
2007-05-04
ACQUASEAL BENZ
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LBH
2007-01-10
RELIEF ACP ORAL CARE GEL
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LBH
2006-11-21
ENAMEL PRO VARNISH
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LBH
2006-10-18
DENSHIELD TREATMENT FOR SENSITIVE TEETH
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LBH
2005-12-16
MULTIPLE (TOOTH DESENSITIZER)
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LBH
2005-09-19
FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502
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LBH
2005-06-07
PROTECT TOOTH DESENSITIZER
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LBH
2004-09-02
ORALIEF THERAPY FOR SENSITIVE TEETH
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LBH
2004-03-10
ORAVIVE TOOTH REVITALIZING PASTE
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LBH
2004-02-04
VARNISHAMERICA
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LBH
2003-10-28
BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN
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LBH
2003-10-17
VIVASENS
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LBH
2003-09-15
FLUORIDE VARNISH
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LBH
2003-05-02
FLUORILAQ
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LBH
2002-11-25
AQUEOUS ACRYLIC DISPERSION 28% W/W
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LBH
2002-09-26
CHLORAPREP
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LBH
2002-08-19
SEAL & PROTECT PROTECTIVE SEALANT
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LBH
2001-12-12
PULPDENT CAVITY PREPARATION IV
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LBH
2001-06-25
QUELL DESENSITIZER
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LBH
2001-04-20
CAVITY VARNISH
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LBH
2001-02-01
PROCLUDE-SENSITIVE
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LBH
2000-10-20
DURAGARD SODIUM FLUORIDE VARNISH
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LBH
2000-03-02
PULPDENT CAVITY PREPARATION III
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LBH
2000-02-29
PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE
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LBH
2000-02-23
PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE
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LBH
1999-11-17
SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE
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LBH
1999-11-17
HEMASEAL & CIDE
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LBH
1999-10-22
D/SENSE II (GREEN-OR) DENTIN DESENSITIZER
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LBH
1999-02-12
SCI-PHARM DFV VARNISH
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LBH
1998-12-17
SCI-PHARM DESENSITIZING VARNISH
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LBH
1998-12-07
GREEN-OR DENTIN DESENSITIZER
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LBH
1998-03-19
PULPDENT CAVITY CLEANSER, PULPDENT CAVITY CLEANSER PLUS
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LBH
1998-02-18
PULPDENT CAVITY VARNISH
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LBH
1997-12-16
CAVITY VARNISH (INTERMEDIARY VARNISH AND DENTINAL TUBULI SEAL)
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LBH
1996-12-12
ULTRADENT UNIVERSAL DENTIN SEALANT
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LBH
1996-08-14
DURAFLOR
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LBH
1996-01-24
ALPHA-DENT COPAL CAVITY VARNISH
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LBH
1995-09-08
ULTRACID F DISINFECTING SOLUTION
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LBH
1995-09-08
ULTRACID DISINFECTING SOLOUTION
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