Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
LBH — Predicate Candidate Screening
138 FDA 510(k) clearances under this product code; the 50 most recent screened below.
89 daysmedian FDA review time
272 days90th percentile
138clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K253052 | Fluoride Varnish (Type A,Type C) | Nagy Oral Technology Qinhuangdao Co., Ltd. | 2026-06-11 | 262 | 0 |
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | 2026-05-01 | 303 | 0 |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 | 1 | 0 |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivit | Sangi Co., Ltd. | 2026-03-18 | 5 | 0 |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 2025-11-21 | 256 | 0 |
| K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Stra | Theodent, LLC | 2025-05-27 | 169 | 0 |
| K241489 | ReminGel | Inter-Med, Inc. | 2025-01-08 | 229 | 0 |
| K241568 | CrystLCare™ PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | 2025-01-02 | 216 | 0 |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | 2024-11-22 | 59 | 0 |
| K233768 | Papacarie Duo | Elevate Oral Care | 2024-07-18 | 237 | 0 |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | 2024-06-13 | 427 | 0 |
| K230333 | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluor | Kettenbach GmbH & Co. KG | 2023-07-24 | 167 | 0 |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | 2023-05-25 | 244 | 0 |
| K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | 2023-05-10 | 2 | 0 |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022-02-16 | 2 | 0 |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | 2020-11-06 | 297 | 0 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 | 108 | 0 |
| K192381 | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizi | Scientific Pharmaceuticals | 2020-02-18 | 172 | 0 |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | 2020-02-11 | 256 | 0 |
| K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | 2020-01-23 | 349 | 0 |
| K182917 | FluoroCal | Bisco, Inc. | 2019-11-18 | 395 | 0 |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | 2019-06-13 | 325 | 0 |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | 2016-12-02 | 296 | 0 |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 | 183 | 1 |
| K151302 | Clinpro Varnish | 3M Company | 2015-09-18 | 126 | 0 |
| K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | 2015-01-29 | 87 | 0 |
| K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | Preventive Technologies, Inc. | 2014-12-12 | 304 | 0 |
| K131487 | FLUOR PROTECTOR S | Ivoclar Vivadent, AG | 2014-10-08 | 503 | 0 |
| K141422 | PROFLUORO FLUORIDE VARNISH | Pac-Dent International, Inc. | 2014-09-30 | 123 | 0 |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Nanova Biomaterials, Inc. | 2014-09-22 | 215 | 0 |
| K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELI | Colgate-Palmolive Company | 2014-06-05 | 99 | 0 |
| K132426 | SYLPHAR REMESENSE SENSITIVITY RELIEF STRIPS | Sylphar N.V. | 2014-02-14 | 193 | 0 |
| K132109 | ENAMELAST | Ultradent Products Inc. / Oratech, LLC | 2013-11-01 | 116 | 0 |
| K124025 | ALPHA-PRO WHITE VARNISH | Dental Technologies, Inc. | 2013-09-18 | 264 | 0 |
| K131376 | SMARTCOAT 2.5% NAF VARNISH | Elevate Oral Care | 2013-08-27 | 105 | 0 |
| K123653 | SEAL BLOCK PRO (NOT FINALIZED), SEAL BLOCK OTC (NOT FINALIZE | Bisco, Inc. | 2013-06-03 | 188 | 0 |
| K122908 | PRG BARRIER COAT | Shofu Dental Corporation | 2013-04-26 | 217 | 0 |
| K122708 | REMESENSE FOR SENSITIVE TEETH | Sylphar N.V. | 2013-01-14 | 132 | 0 |
| K122331 | CAVITY VARNISH | Dentsply International, Inc. | 2012-10-15 | 74 | 0 |
| K120176 | SENZZZZZ AWAY | Centrix, Inc. | 2012-07-25 | 187 | 0 |
| K120109 | SUPER SEAL TOOTH DESENSITIZER | Phoenix Dental, Inc. | 2012-03-07 | 54 | 0 |
| K113146 | PCXX VARNISH | Ross Healthcare, Inc. | 2012-01-23 | 91 | 0 |
| K112946 | ACTIV VARNISH | Pulpdent Corporation | 2011-12-09 | 66 | 0 |
| K103461 | COLGATE DESENSITIZING DENTAL CREAM | Colgate-Palmolive Co. | 2011-09-13 | 293 | 0 |
| K103160 | NUPRO MODEL 13016901 | CAO Group, Inc. | 2011-01-06 | 72 | 0 |
| K102808 | MI VARNISH | GC America, Inc. | 2010-12-22 | 85 | 0 |
| K100172 | TOKUYAMA SHIELD FORCE | Tokuyama Dental Corporation | 2010-10-21 | 273 | 0 |
| K100540 | ASCENT F-COAT MODEL: 006-00097 | CAO Group, Inc. | 2010-09-23 | 210 | 0 |
| K100503 | PULPDENT COPAL VARNISH WITH FLUORIDE | Pulpdent Corporation | 2010-05-12 | 79 | 0 |
| K093620 | PULPDENT FLUORIDE VARNISH | Pulpdent Corporation | 2010-03-10 | 107 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda