FDA Product Code
FDA Product Code LBH — Clearance Directory
- Device Class
- Class II
- Assigned Panel
- Dental
- 21 CFR Citation
- 872.3260
510(k) Clearances — 139 records · page 1 of 2
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K262243 | Profisil Free | Kettenbach GmbH & Co. KG | 2026-09-03 | Traditional | PDF ↗ |
| K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026-06-11 | Traditional | PDF ↗ |
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | 2026-05-01 | Traditional | PDF ↗ |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 | Special | PDF ↗ |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026-03-18 | Traditional | PDF ↗ |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 2025-11-21 | Traditional | PDF ↗ |
| K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% / Bubble Gum) | Theodent, LLC | 2025-05-27 | Traditional | PDF ↗ |
| K241489 | ReminGel | Inter-Med, Inc. | 2025-01-08 | Traditional | PDF ↗ |
| K241568 | CrystLCare PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | 2025-01-02 | Traditional | PDF ↗ |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | 2024-11-22 | Traditional | PDF ↗ |
| K233768 | Papacarie Duo | Elevate Oral Care | 2024-07-18 | Traditional | PDF ↗ |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | 2024-06-13 | Traditional | PDF ↗ |
| K230333 | 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) | Kettenbach GmbH & Co. KG | 2023-07-24 | Traditional | PDF ↗ |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | 2023-05-25 | Traditional | PDF ↗ |
| K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | 2023-05-10 | Traditional | PDF ↗ |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022-02-16 | Traditional | PDF ↗ |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | 2020-11-06 | Traditional | PDF ↗ |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 | Traditional | PDF ↗ |
| K192381 | 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 | Scientific Pharmaceuticals | 2020-02-18 | Traditional | PDF ↗ |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | 2020-02-11 | Traditional | PDF ↗ |
| K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | 2020-01-23 | Traditional | PDF ↗ |
| K182917 | FluoroCal | Bisco, Inc. | 2019-11-18 | Traditional | PDF ↗ |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | 2019-06-13 | Traditional | PDF ↗ |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | 2016-12-02 | Traditional | PDF ↗ |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 | Traditional | PDF ↗ |
| K151302 | Clinpro Varnish | 3M Company | 2015-09-18 | Traditional | PDF ↗ |
| K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | 2015-01-29 | Traditional | PDF ↗ |
| K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | Preventive Technologies, Inc. | 2014-12-12 | Traditional | PDF ↗ |
| K131487 | FLUOR PROTECTOR S | Ivoclar Vivadent, AG | 2014-10-08 | Traditional | PDF ↗ |
| K141422 | PROFLUORO FLUORIDE VARNISH | Pac-Dent International, Inc. | 2014-09-30 | Traditional | PDF ↗ |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Nanova Biomaterials, Inc. | 2014-09-22 | Traditional | PDF ↗ |
| K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH | Colgate-Palmolive Company | 2014-06-05 | Traditional | PDF ↗ |
| K132426 | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS | Sylphar N.V. | 2014-02-14 | Traditional | PDF ↗ |
| K132109 | ENAMELAST | Ultradent Products Inc. / Oratech, LLC | 2013-11-01 | Traditional | PDF ↗ |
| K124025 | ALPHA-PRO WHITE VARNISH | Dental Technologies, Inc. | 2013-09-18 | Traditional | PDF ↗ |
| K131376 | SMARTCOAT 2.5% NAF VARNISH | Elevate Oral Care | 2013-08-27 | Traditional | PDF ↗ |
| K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) | Bisco, Inc. | 2013-06-03 | Traditional | PDF ↗ |
| K122908 | PRG BARRIER COAT | Shofu Dental Corporation | 2013-04-26 | Traditional | PDF ↗ |
| K122708 | REMESENSE FOR SENSITIVE TEETH | Sylphar N.V. | 2013-01-14 | Traditional | PDF ↗ |
| K122331 | CAVITY VARNISH | Dentsply International, Inc. | 2012-10-15 | Traditional | PDF ↗ |
| K120176 | SENZZZZZ AWAY | Centrix, Inc. | 2012-07-25 | Traditional | PDF ↗ |
| K120109 | SUPER SEAL TOOTH DESENSITIZER | Phoenix Dental, Inc. | 2012-03-07 | Traditional | PDF ↗ |
| K113146 | PCXX VARNISH | Ross Healthcare, Inc. | 2012-01-23 | Abbreviated | PDF ↗ |
| K112946 | ACTIV VARNISH | Pulpdent Corporation | 2011-12-09 | Traditional | PDF ↗ |
| K103461 | COLGATE DESENSITIZING DENTAL CREAM | Colgate-Palmolive Co. | 2011-09-13 | Traditional | PDF ↗ |
| K103160 | NUPRO MODEL 13016901 | CAO Group, Inc. | 2011-01-06 | Traditional | PDF ↗ |
| K102808 | MI VARNISH | GC America, Inc. | 2010-12-22 | Traditional | PDF ↗ |
| K100172 | TOKUYAMA SHIELD FORCE | Tokuyama Dental Corporation | 2010-10-21 | Traditional | PDF ↗ |
| K100540 | ASCENT F-COAT MODEL: 006-00097 | CAO Group, Inc. | 2010-09-23 | Traditional | PDF ↗ |
| K100503 | PULPDENT COPAL VARNISH WITH FLUORIDE | Pulpdent Corporation | 2010-05-12 | Traditional | PDF ↗ |
| K092141 | VANISH VARNISH, 5% SODIUM FLUORIDE WHITE VARNISH | 3M Espe Dental Products | 2010-03-10 | Traditional | PDF ↗ |
| K093620 | PULPDENT FLUORIDE VARNISH | Pulpdent Corporation | 2010-03-10 | Traditional | PDF ↗ |
| K093575 | GLUMA DESENSITIZER POWER GEL | Heraeus Kulzer, LLC | 2010-03-05 | Traditional | PDF ↗ |
| K090519 | VANISH VARNISH, 5% SODIUM FLUORIDE VARNISH, MODEL 12245, VANISH VARNISH, 5% FLUORIDE VARNISH, MODEL 12247 | 3M Company | 2009-04-15 | Special | PDF ↗ |
| K082594 | REMESENSE | Remedent NV | 2009-03-19 | Traditional | PDF ↗ |
| K090597 | FLUORILAQ SODIUM FLUORIDE CAVITY VARNISH | Pascal Co., Inc. | 2009-03-16 | Special | PDF ↗ |
| K083036 | VOCO PROFLUORID L | Voco GmbH | 2009-01-12 | Traditional | PDF ↗ |
| K082198 | DURASHIELD PLUS | Dentsply Intl., Inc. | 2008-10-29 | Traditional | PDF ↗ |
| K082071 | ADPHARMA OCCLUDE AND OCCLUDE F DENTIN TUBULE AGENT | Adpharma, Inc. | 2008-10-02 | Traditional | PDF ↗ |
| K080814 | VOCO PROFLUORID VARNISH | Voco GmbH | 2008-07-24 | Traditional | PDF ↗ |
| K080228 | ORALIEF OTC TOOTHPASTE FOR SENSITIVE TEETH | Novamin Technology, Inc. | 2008-03-27 | Traditional | PDF ↗ |
| K073061 | THE PROXIVENT KIT | Coll Partners , Ltd. | 2008-02-29 | Traditional | PDF ↗ |
| K080249 | FLOR-OPAL VARNISH WHITE; MODELS 4503, 4504, 4506, S4505 | Ultradent Products, Inc. | 2008-02-08 | Special | PDF ↗ |
| K073117 | DENTIN DESENSITIZER AGENT | Dentsply Intl., Inc. | 2007-12-19 | Traditional | PDF ↗ |
| K072342 | SULTAN TOOTH ROOT DESENSITIZER | Dentsply International, Inc. | 2007-10-03 | Traditional | PDF ↗ |
| K072338 | CERVITEC PLUS | Ivoclar Vivadent, Inc. | 2007-09-21 | Traditional | PDF ↗ |
| K061438 | ULTRAEZ DESENSITIZING GEL | Ultradent Products, Inc. | 2007-06-12 | Traditional | PDF ↗ |
| K070070 | ASCENT DENTAL CLEANSER | CAO Group, Inc. | 2007-05-25 | Traditional | PDF ↗ |
| K071267 | PERIOSRP TOOTH ROOT CONDITIONER WITH NOVAMIN | Novamin Technology, Inc. | 2007-05-18 | Special | PDF ↗ |
| K070289 | ACQUASEAL BENZ | Acquamed Technologies, Inc. | 2007-05-04 | Traditional | PDF ↗ |
| K062176 | RELIEF ACP ORAL CARE GEL | Discus Dental, Inc. | 2007-01-10 | Traditional | PDF ↗ |
| K062683 | ENAMEL PRO VARNISH | Premier Dental Products Co. | 2006-11-21 | Traditional | PDF ↗ |
| K061359 | DENSHIELD TREATMENT FOR SENSITIVE TEETH | Novamin Technology, Inc. | 2006-10-18 | Traditional | PDF ↗ |
| K052263 | MULTIPLE (TOOTH DESENSITIZER) | Cosmedent, Inc. | 2005-12-16 | Traditional | PDF ↗ |
| K051750 | FLOR-OPAL VARNISH, MODELS UP 4500/ UP 4501/ UP 4502 | Ultradent Products, Inc. | 2005-09-19 | Traditional | PDF ↗ |
| K050486 | PROTECT TOOTH DESENSITIZER | Sunstar Butler | 2005-06-07 | Traditional | PDF ↗ |
| K040858 | ORALIEF THERAPY FOR SENSITIVE TEETH | Novamin Technology, Inc. | 2004-09-02 | Traditional | PDF ↗ |
| K040473 | ORAVIVE TOOTH REVITALIZING PASTE | Novamin Technology, Inc. | 2004-03-10 | Traditional | PDF ↗ |
| K040098 | VARNISHAMERICA | Medical Products Laboratories, Inc. | 2004-02-04 | Traditional | PDF ↗ |
| K033295 | BUTLER NUCARE ROOT CONDITIONER WITH NOVAMIN | Novamin Technology, Inc. | 2003-10-28 | Traditional | PDF ↗ |
| K030922 | VIVASENS | Ivoclar Vivadent, Inc. | 2003-10-17 | Traditional | PDF ↗ |
| K031932 | FLUORIDE VARNISH | Dentsply Intl. | 2003-09-15 | Traditional | PDF ↗ |
| K030488 | FLUORILAQ | Pascal Co., Inc. | 2003-05-02 | Traditional | PDF ↗ |
| K023671 | AQUEOUS ACRYLIC DISPERSION 28% W/W | Chx Technologies, Inc. | 2002-11-25 | Special | PDF ↗ |
| K021131 | CHLORAPREP | Centrix, Inc. | 2002-09-26 | Traditional | PDF ↗ |
| K021805 | SEAL & PROTECT PROTECTIVE SEALANT | Dentsply Intl. | 2002-08-19 | Traditional | PDF ↗ |
| K013411 | PULPDENT CAVITY PREPARATION IV | Pulpdent Corp. | 2001-12-12 | Traditional | PDF ↗ |
| K010957 | QUELL DESENSITIZER | Jeneric/Pentron, Inc. | 2001-06-25 | Traditional | PDF ↗ |
| K010255 | CAVITY VARNISH | Rite-Dent Manufacturing Corp. | 2001-04-20 | Traditional | PDF ↗ |
| K003482 | PROCLUDE-SENSITIVE | Ortek Therapeutics, Inc. | 2001-02-01 | Traditional | PDF ↗ |
| K002581 | DURAGARD SODIUM FLUORIDE VARNISH | Sultan Dental Products, Ltd. | 2000-10-20 | Traditional | PDF ↗ |
| K994180 | PULPDENT CAVITY PREPARATION III | Pulpdent Corp. | 2000-03-02 | Traditional | PDF ↗ |
| K994181 | PULPDENT CAVITY PREPARATION II, PULPDENT CAVITY PREPARATION II WUTH FLUORIDE | Pulpdent Corp. | 2000-02-29 | Traditional | PDF ↗ |
| K994182 | PULPDENT CAVITY PREPARATION 1, PULPDENT CAVITY PREPARATION 1 WITH FLUORIDE | Pulpdent Corp. | 2000-02-23 | Traditional | PDF ↗ |
| K990779 | HEMASEAL & CIDE | Advantage Dental Products, Inc. | 1999-11-17 | Traditional | PDF ↗ |
| K992822 | SEAL & PROTECT PROTECTIVE SEALANT FOR EXPOSED DENTINE | Dentsply Intl. | 1999-11-17 | Traditional | PDF ↗ |
| K992629 | D/SENSE II (GREEN-OR) DENTIN DESENSITIZER | Centrix, Inc. | 1999-10-22 | Traditional | PDF ↗ |
| K982915 | SCI-PHARM DFV VARNISH | Scientific Pharmaceuticals, Inc. | 1999-02-12 | Traditional | PDF ↗ |
| K983305 | SCI-PHARM DESENSITIZING VARNISH | Scientific Pharmaceuticals, Inc. | 1998-12-17 | Traditional | PDF ↗ |
| K981972 | GREEN-OR DENTIN DESENSITIZER | Centrix, Inc. | 1998-12-07 | Traditional | PDF ↗ |
Product code LBH · Class II · Dental. Data: openFDA.