FiteBac Cavity Cleanser— 510(k) K190271

Substantially Equivalent

Largent Health, LLC

FDA 510(k) clearance K190271 for FiteBac Cavity Cleanser, Substantially Equivalent on 2020-01-23. Applicant: Largent Health, LLC. Device class: 2.

Clearance details

Applicant: Largent Health, LLC
Product code: Code LBH
Device class: Class 2
Regulation: 21 CFR 872.3260
Advisory panel: Dental
Date received: 2019-02-08
Decision date: 2020-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBH

K262243 — Profisil Free2026-09-03
K253052 — Fluoride Varnish (Type A,Type C)2026-06-11
K252073 — VOCO Profluorid Varnish + BioMin2026-05-01
K261404 — UltraEZ2026-04-30
K260830 — APAPRO Desensitizer Homecare (Remineralizing Anti-sensitivity Toothpaste)2026-03-18

More clearances from Largent Health, LLC

K210115 — FiteBac CC OrthoSeal2021-07-29
K200614 — FiteBac Antimicrobial Cavity Cleanser2020-06-25

Data sourced from openFDA. This site is unofficial and independent of the FDA.