510(k) Report

FDA applicant

Flossbrush Interdental Cleaner and Applicator

San Francisco, CA1 decision1997–19970 recalls

FDA records 1 decision for Flossbrush Interdental Cleaner and Applicator (San Francisco, CA) in 1997: 1 510(k) clearance. All are in product code JES (Floss, Dental). 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 Flossbrush Interdental Cleaner and Applicator’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Flossbrush Interdental Cleaner and Applicator since 2007.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Flossbrush Interdental Cleaner and Applicator 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?

  • JESFloss, Dental1decision

What has FDA decided for it lately?

  • K964976Flossbrush with FluorideFlossbrush Interdental Cleaner and Applicator · 1997

The one decision as Flossbrush Interdental Cleaner and Applicator →