Cleared Traditional

FiteBac Antimicrobial Cavity Cleanser

K200614 · Largent Health, LLC · Dental

Jun 2020

Decision

108d

Days

Class 2

Risk

About This 510(k) Submission

K200614 is an FDA 510(k) clearance for the FiteBac Antimicrobial 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 June 25, 2020, 108 days after receiving the submission on March 9, 2020. This device falls under the Dental review panel. Regulated under 21 CFR 872.3260.

Submission Details

510(k) Number	K200614 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 09, 2020
Decision Date	June 25, 2020
Days to Decision	108 days
Submission Type	Traditional
Review Panel	Dental (DE)
Summary	Summary PDF