510(k) Report

FDA applicant

Breathaid, LLC

Columbia, SC1 decision1998–19980 recalls

FDA records 1 decision for Breathaid, LLC (Columbia, SC) in 1998: 1 510(k) clearance. All are in product code LCN (Scraper, Tongue). 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 Breathaid, LLC’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Breathaid, LLC since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Breathaid, LLC by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LCNScraper, Tongue1decision

What has FDA decided for it lately?

  • K981808Breathaid Tongue ScraperBreathaid, LLC · 1998

The one decision as Breathaid, LLC →