LBH — Varnish, Cavity Class II
FDA product code LBH covers "Varnish, Cavity", a Class II medical device regulated under 21 CFR 872.3260. Submissions are reviewed by the Dental panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- LBH
- Device Class
- Class II
- Regulation Number
- 872.3260
- Submission Type
- Review Panel
- DE
- Medical Specialty
- Dental
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K253052 | nagy oral technology qinhuangdao co | Fluoride Varnish (Type A,Type C) | June 11, 2026 |
| K252073 | voco | VOCO Profluorid Varnish + BioMin | May 1, 2026 |
| K261404 | ultradent products | UltraEZ | April 30, 2026 |
| K260830 | sangi co | APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste) | March 18, 2026 |
| K250714 | centrix | FluoroDose Varnish | November 21, 2025 |
| K243777 | theodent | Rennou Varnish (3% / Spearmint); Rennou Varnish (3% / Strawberry); Rennou Var | May 27, 2025 |
| K241489 | inter-med | ReminGel | January 8, 2025 |
| K241568 | greenmark biomedical | CrystLCare PRO Biorestorative, Fluoride-Plus | January 2, 2025 |
| K242913 | jasberry healthcare private limited | Jasmate® Toothpaste | November 22, 2024 |
| K233768 | elevate oral care | Papacarie Duo | July 18, 2024 |
| K231060 | belport company, inc., gingi-pak | ProMin Dental Desensitizing Gel | June 13, 2024 |
| K230333 | kettenbach gmbh and co. kg | Profisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal | July 24, 2023 |
| K222891 | guangzhou beogene biotech co | Dental Desensitizer | May 25, 2023 |
| K231338 | 3m espe dental products | 3M Clinpro Clear 2.1% Sodium Fluoride Treatment | May 10, 2023 |
| K220419 | sangi co | Apapro Desensitizer | February 16, 2022 |
| K200077 | collins | BioMin Restore Plus | November 6, 2020 |
| K200614 | largent health | FiteBac Antimicrobial Cavity Cleanser | June 25, 2020 |
| K192381 | scientific pharmaceuticals | DFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-Bubblegum | February 18, 2020 |
| K191453 | ivoclar vivadent | Cervitec F | February 11, 2020 |
| K190271 | largent health | FiteBac Cavity Cleanser | January 23, 2020 |