LBH
- Product code
- LBH
- Device name
- Varnish, Cavity
- Device class
- Class 2
- 21 CFR
- 21 CFR 872.3260
- Medical specialty
- Dental
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 11
- Summaries archived here
- 7 (direct download)
- 510(k) clearances (all years, FDA)
- 138 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (11)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K253052 | 2026-06-11 | Nagy Oral Technology Qinhuangdao Co., … | Fluoride Varnish (Type A,Type C) | FDA |
| K252073 | 2026-05-01 | Voco GmbH | VOCO Profluorid Varnish + BioMin | — |
| K261404 | 2026-04-30 | Ultradent Products, Inc. | UltraEZ | |
| K260830 | 2026-03-18 | Sangi Co., Ltd. | APAPRO Desensitizer Homecare (Remineralizing Anti-se… | |
| K250714 | 2025-11-21 | Centrix, Inc. | FluoroDose Varnish | |
| K243777 | 2025-05-27 | Theodent, LLC | Rennou Varnish (3% / Spearmint); Rennou Varnish (3… | |
| K241489 | 2025-01-08 | Inter-Med, Inc. | ReminGel | FDA |
| K241568 | 2025-01-02 | GreenMark Biomedical, Inc. | CrystLCare PRO Biorestorative, Fluoride-Plus | |
| K242913 | 2024-11-22 | Jasberry Healthcare Private Limited | Jasmate® Toothpaste | |
| K233768 | 2024-07-18 | Elevate Oral Care | Papacarie Duo | |
| K231060 | 2024-06-13 | Belport Company, Inc., Gingi-Pak | ProMin Dental Desensitizing Gel | — |
Official FDA classification page: LBH
Classification and pathway per current FDA publications. Data from openFDA (CC0).