Product code LBH
- Device name
- Varnish, Cavity
- Medical specialty
- Dental
- Device class
- 2
- Regulation number
- 872.3260
- Review panel
- DE
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252073 | VOCO Profluorid Varnish + BioMin | Voco GmbH | 2026-05-01 |
| K261404 | UltraEZ | Ultradent Products, Inc. | 2026-04-30 |
| K260830 | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | Sangi Co., Ltd. | 2026-03-18 |
| K250714 | FluoroDose Varnish | Centrix, Inc. | 2025-11-21 |
| K243777 | Rennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ Varnish (3% / Cherry); Rennou™ Varnish (3% / Bubble Gum) | Theodent, LLC | 2025-05-27 |
| K241489 | ReminGel | Inter-Med, Inc. | 2025-01-08 |
| K241568 | CrystLCare™ PRO Biorestorative, Fluoride-Plus | GreenMark Biomedical, Inc. | 2025-01-02 |
| K242913 | Jasmate® Toothpaste | Jasberry Healthcare Private Limited | 2024-11-22 |
| K233768 | Papacarie Duo | Elevate Oral Care | 2024-07-18 |
| K231060 | ProMin Dental Desensitizing Gel | Belport Company, Inc., Gingi-Pak | 2024-06-13 |
| 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 Sa... | Kettenbach GmbH & Co. KG | 2023-07-24 |
| K222891 | Dental Desensitizer | Guangzhou Beogene Biotech Co., Ltd. | 2023-05-25 |
| K231338 | 3M™ Clinpro™ Clear 2.1% Sodium Fluoride Treatment | 3M Espe Dental Products | 2023-05-10 |
| K220419 | Apapro Desensitizer | Sangi Co., Ltd. | 2022-02-16 |
| K200077 | BioMin Restore Plus | Dr. Collins, Inc. | 2020-11-06 |
| K200614 | FiteBac Antimicrobial Cavity Cleanser | Largent Health, LLC | 2020-06-25 |
| 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 |
| K191453 | Cervitec F | Ivoclar Vivadent, AG | 2020-02-11 |
| K190271 | FiteBac Cavity Cleanser | Largent Health, LLC | 2020-01-23 |
| K182917 | FluoroCal | Bisco, Inc. | 2019-11-18 |
| K181965 | Restore Toothpaste | Dr. Collins, Inc. | 2019-06-13 |
| K160377 | V-varnish Premium | Vericom Co., Ltd. | 2016-12-02 |
| K153334 | Oral-B 5% Sodium Fluoride Varnish | Young Dental Manufacturing Co. 1, LLC | 2016-05-20 |
| K151302 | Clinpro Varnish | 3M Company | 2015-09-18 |
| K143155 | LISTERINE Sensitivity Defense Mouthrinse | Johnson & Johnson Healthcare Products, Division of Mcneil-Pp | 2015-01-29 |
| K140350 | VELLA 5% SODIUM FLUORIDE VARNISH WITH NUFLUOR AND XYLITOL | Preventive Technologies, Inc. | 2014-12-12 |
| K131487 | FLUOR PROTECTOR S | Ivoclar Vivadent, AG | 2014-10-08 |
| K141422 | PROFLUORO FLUORIDE VARNISH | Pac-Dent International, Inc. | 2014-09-30 |
| K140349 | STARBRIGHT 5% SODIUM FLUORIDE VARNISH | Nanova Biomaterials, Inc. | 2014-09-22 |
| K140481 | COLGATE DESENSITIZING MOUTHRINSE, COLGATE SENSITIVE PRO-RELIEF MOUTHWASH | Colgate-Palmolive Company | 2014-06-05 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07615208299373 | Cervitec Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-07-10 |
| 07615208292893 | Cervitec Plus | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2025-03-20 |
| 07615208474459 | Adhese Universal | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-04-05 |
| 07615208474091 | Adhese Universal | IVOCLAR VIVADENT AKTIENGESELLSCHAFT | 2024-03-25 |
| 10302730700104 | Varnish America 0.25ml Box / 32 Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730701217 | Varnish America 0.4ml Box / 200 White Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700111 | Varnish America 0.25ml Box / 32 Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700203 | Varnish America 0.4ml Box / 200 Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700210 | Varnish America 0.4ml Box / 200 Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700227 | Varnish America 0.4ml Box / 200 Mint | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700302 | Varnish America 0.25ml Box / 200 Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700319 | Varnish America 0.25ml Box / 200 Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700326 | Varnish America 0.25ml Box / 200 Mint | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730701019 | Varnish America 0.4ml Box / 32 White Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730701101 | Varnish America 0.25ml Box / 32 White Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730701118 | Varnish America 0.25ml Box / 32 White Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730701200 | Varnish America 0.4ml Box / 200 White Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700012 | Varnish America 0.4ml Box / 32 Raspberry | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 10302730700005 | Varnish America 0.4ml Box / 32 Bubblegum | YOUNG DENTAL MANUFACTURING I, LLC | 2017-08-31 |
| 08809254453431 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453424 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453400 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453394 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453370 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453363 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453356 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453349 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| 08809254453332 | V-varnish Premium | VERICOM CO., LTD. | 2017-02-21 |
| J014660400930 | iBOND Total Etch Single Dose Refill | Kulzer GmbH | 2016-09-15 |
| J014660398660 | iBOND Total Etch Bottle Assortment | Kulzer GmbH | 2016-09-15 |