510(k) Report

FDA applicant

Largent Health, LLC

Marietta, GA3 decisions2020–20210 recalls

FDA records 3 decisions for Largent Health, LLC (Marietta, GA) from 2020 to 2021: 3 510(k) clearances. Most are in product codes LBH (Varnish, Cavity) and DYH (Adhesive, Bracket And Tooth Conditioner, Resin). Its devices cite 4 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, dental panel, where it files most

How often FDA has decided Largent Health, LLC’s devices, and how often a recall has named them.

FDA decisions per year

1in 2021

2020: 22021: 1
2020high 2 (2020) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2020.

FIG. 1 — Largent Health, LLC by year, 2020–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Largent Health, LLC’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • LBHVarnish, Cavity2decisions
  • DYHAdhesive, Bracket And Tooth Conditioner, Resin1decision

Whose devices does it build on?

Its devices cite 4 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 2 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K190271FiteBac Cavity CleanserLargent Health, LLC · 20202cite it

What has FDA decided for it lately?

  • K210115FiteBac CC OrthoSealLargent Health, LLC · 2021
  • K200614FiteBac Antimicrobial Cavity CleanserLargent Health, LLC · 2020
  • K190271FiteBac Cavity CleanserLargent Health, LLC · 2020

All 3 as Largent Health, LLC →