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LBH — Varnish, Cavity Class II

FDA Device Classification

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-NumberApplicantDevice NameDate
K250714centrixFluoroDose VarnishNovember 21, 2025
K243777theodentRennou™ Varnish (3% / Spearmint); Rennou™ Varnish (3% / Strawberry); Rennou™ VarMay 27, 2025
K241489inter-medReminGelJanuary 8, 2025
K241568greenmark biomedicalCrystLCare™ PRO Biorestorative, Fluoride-PlusJanuary 2, 2025
K242913jasberry healthcare private limitedJasmate® ToothpasteNovember 22, 2024
K233768elevate oral carePapacarie DuoJuly 18, 2024
K231060belport company, inc., gingi-pakProMin Dental Desensitizing GelJune 13, 2024
K230333kettenbach gmbh and co. kgProfisil Fluoride Varnish Combi pack (14801), Profisil Fluoride Varnish Normal July 24, 2023
K222891guangzhou beogene biotech coDental DesensitizerMay 25, 2023
K2313383m espe dental products3M™ Clinpro™ Clear 2.1% Sodium Fluoride TreatmentMay 10, 2023
K220419sangi coApapro DesensitizerFebruary 16, 2022
K200077collinsBioMin Restore PlusNovember 6, 2020
K200614largent healthFiteBac Antimicrobial Cavity CleanserJune 25, 2020
K192381scientific pharmaceuticalsDFV Desensitizing Varnish-Strawberry Flavor, DFV Desensitizing Varnish-BubblegumFebruary 18, 2020
K191453ivoclar vivadentCervitec FFebruary 11, 2020
K190271largent healthFiteBac Cavity CleanserJanuary 23, 2020
K182917biscoFluoroCalNovember 18, 2019
K181965collinsRestore ToothpasteJune 13, 2019
K160377vericom coV-varnish PremiumDecember 2, 2016
K153334young dental manufacturing co. 1Oral-B 5% Sodium Fluoride VarnishMay 20, 2016