Varnish, Cavity
Regulation 872.3260
6510(k)s in 12 months (139 all time)
0recalls in 12 months (9 all time)
6recalls that name a 510(k)
Top companies in LBH
| Company | 510(k)s | Recalls |
|---|---|---|
| Pulpdent Corp. | 10 | 0 |
| Ultradent Products, Inc. | 9 | 1 |
| Scientific Pharmaceuticals | 9 | 0 |
| Dentsply Intl. | 6 | 0 |
| Novamin Technology, Inc. | 6 | 0 |
| Centrix, Inc. | 5 | 0 |
| Ivoclar Vivadent, AG | 4 | 0 |
| CAO Group, Inc. | 3 | 0 |
| Dental Dimensions Supply Co. | 3 | 0 |
| Voco GmbH | 3 | 0 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Sep 3, 2026 | K262243 | Profisil Free Kettenbach GmbH & Co. KG, DE | LBH |
| Jun 11, 2026 | K253052 | Fluoride Varnish (Type A,Type C) Nagy Oral Technology Qinhuangdao Co., Ltd., CN | LBH |
| May 1, 2026 | K252073 | VOCO Profluorid Varnish + BioMin Voco GmbH, DE | LBH |
| Apr 30, 2026 | K261404 | UltraEZ Ultradent Products, Inc. | LBH |
| Mar 18, 2026 | K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) Sangi Co., Ltd., JP | LBH |
| Nov 21, 2025 | K250714 | FluoroDose Varnish Centrix, Inc. | LBH |
| May 27, 2025 | K243777 | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Varnish (3% / Cherry); Rennou Varnish (3% Theodent, LLC | LBH |
| Jan 8, 2025 | K241489 | ReminGel Inter-Med, Inc. | LBH |
| Jan 2, 2025 | K241568 | CrystLCare PRO Biorestorative, Fluoride-Plus GreenMark Biomedical, Inc. | LBH |
| Nov 22, 2024 | K242913 | Jasmate® Toothpaste Jasberry Healthcare Private Limited, IN | LBH |
| Jul 18, 2024 | K233768 | Papacarie Duo Elevate Oral Care | LBH |
| Jun 13, 2024 | K231060 | ProMin Dental Desensitizing Gel Belport Company, Inc., Gingi-Pak | LBH |
| Jul 24, 2023 | K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal pack mint (14802), Profisil Fluoride Var Kettenbach GmbH & Co. KG, DE | LBH |
| May 25, 2023 | K222891 | Dental Desensitizer Guangzhou Beogene Biotech Co., Ltd., CN | LBH |
| May 10, 2023 | K231338 | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment 3M Espe Dental Products | LBH |
| Feb 16, 2022 | K220419 | Apapro Desensitizer Sangi Co., Ltd., JP | LBH |
| Nov 6, 2020 | K200077 | BioMin Restore Plus Dr. Collins, Inc. | LBH |
| Jun 25, 2020 | K200614 | FiteBac Antimicrobial Cavity Cleanser Largent Health, LLC | LBH |
| Feb 18, 2020 | K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum (Tutti-Fruity) Flavor, DFV Desensitizin Scientific Pharmaceuticals | LBH |
| Feb 11, 2020 | K191453 | Cervitec F Ivoclar Vivadent, AG, LI | LBH |
| Jan 23, 2020 | K190271 | FiteBac Cavity Cleanser Largent Health, LLC | LBH |
| Nov 18, 2019 | K182917 | FluoroCal Bisco, Inc. | LBH |
| Jun 13, 2019 | K181965 | Restore Toothpaste Dr. Collins, Inc. | LBH |
| Dec 2, 2016 | K160377 | V-varnish Premium Vericom Co., Ltd., KR | LBH |
| May 20, 2016 | K153334 | Oral-B 5% Sodium Fluoride Varnish Young Dental Manufacturing Co. 1, LLC | LBH |
| Sep 18, 2015 | K151302 | Clinpro Varnish 3M Company | LBH |
| Jan 29, 2015 | K143155 | LISTERINE Sensitivity Defense Mouthrinse Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | LBH |
| Dec 12, 2014 | K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL Preventive Technologies, Inc. | LBH |
| Oct 8, 2014 | K131487 | FLUOR PROTECTOR S Ivoclar Vivadent, AG | LBH |
| Sep 30, 2014 | K141422 | PROFLUORO FLUORIDE VARNISH Pac-Dent International, Inc. | LBH |
| Sep 22, 2014 | K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH Nanova Biomaterials, Inc. | LBH |
| Jun 5, 2014 | K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH Colgate-Palmolive Company | LBH |
| Feb 14, 2014 | K132426 | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS Sylphar N.V., IT | LBH |
| Nov 1, 2013 | K132109 | ENAMELAST Ultradent Products Inc. / Oratech, LLC | LBH |
| Sep 18, 2013 | K124025 | ALPHA-PRO WHITE VARNISH Dental Technologies, Inc. | LBH |
| Aug 27, 2013 | K131376 | SMARTCOAT 2.5% NAF VARNISH Elevate Oral Care | LBH |
| Jun 3, 2013 | K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZED) Bisco, Inc. | LBH |
| Apr 26, 2013 | K122908 | PRG BARRIER COAT Shofu Dental Corporation | LBH |
| Jan 14, 2013 | K122708 | REMESENSE FOR SENSITIVE TEETH Sylphar N.V., IT | LBH |
| Oct 15, 2012 | K122331 | CAVITY VARNISH Dentsply International, Inc. | LBH |
| Jul 25, 2012 | K120176 | SENZZZZZ AWAY Centrix, Inc. | LBH |
| Mar 7, 2012 | K120109 | SUPER SEAL TOOTH DESENSITIZER Phoenix Dental, Inc. | LBH |
| Jan 23, 2012 | K113146 | PCXX VARNISH Ross Healthcare, Inc. | LBH |
| Dec 9, 2011 | K112946 | ACTIV VARNISH Pulpdent Corporation | LBH |
| Sep 13, 2011 | K103461 | COLGATE DESENSITIZING DENTAL CREAM Colgate-Palmolive Co. | LBH |
| Jan 6, 2011 | K103160 | NUPRO MODEL 13016901 CAO Group, Inc. | LBH |
| Dec 22, 2010 | K102808 | MI VARNISH GC America, Inc. | LBH |
| Oct 21, 2010 | K100172 | TOKUYAMA SHIELD FORCE Tokuyama Dental Corporation | LBH |
| Sep 23, 2010 | K100540 | ASCENT F-COAT MODEL: 006-00097 CAO Group, Inc. | LBH |
| May 12, 2010 | K100503 | PULPDENT COPAL VARNISH WITH FLUORIDE Pulpdent Corporation | LBH |
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