Cleared Traditional

FiteBac Cavity Cleanser

K190271 · Largent Health, LLC · Dental

Jan 2020

Decision

349d

Days

Class 2

Risk

About This 510(k) Submission

K190271 is an FDA 510(k) clearance for the FiteBac Cavity Cleanser, a Varnish, Cavity (Class II — Special Controls, product code LBH), submitted by Largent Health, LLC (Marietta, US). The FDA issued a Cleared decision on January 23, 2020, 349 days after receiving the submission on February 8, 2019. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K190271 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 08, 2019
Decision Date	January 23, 2020
Days to Decision	349 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF