510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
Medical Device
ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
SUBSCRIBE / SIGN IN
K200614Substantially Equivalent

FiteBac Antimicrobial Cavity Cleanser

Largent Health, LLC, Marietta GA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K200614 is the FDA 510(k) clearance record for FiteBac Antimicrobial Cavity Cleanser, a class II device, cleared for Largent Health, LLC on under FDA product code LBH (Varnish, Cavity). FDA records list 3 510(k) clearances for Largent Health, LLC, from to . As of , FDA records show no recalls naming K200614.

Clearance record

Decision date
Received
(108 days to decision)
Product code
LBH Varnish, Cavity
Regulation
21 CFR 872.3260
Device class
Class II
Review panel
Dental
Applicant
Largent Health, LLC 3698 Largent Way NW, Suite 101, Marietta GA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LBH

Trailing 12 months
6 clearances under product code LBH in the twelve months to October 2026, November 2025 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LBH, trailing twelve months
MonthClearances
November 20251
December 20250
January 20260
February 20260
March 20261
April 20261
May 20261
June 20261
July 20260
August 20260
September 20261
October 20260