FDA applicant

Classone Orthodontics, Inc.

Lubbock, TX3 decisions2006–20100 recalls

FDA records 3 decisions for Classone Orthodontics, Inc. (Lubbock, TX) from 2006 to 2010: 3 510(k) clearances. Most are in product codes DYH (Adhesive, Bracket And Tooth Conditioner, Resin) and EBC (Sealant, Pit And Fissure, And Conditioner). 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 Classone Orthodontics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2010

2007high 1 (2008) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Classone Orthodontics, Inc.

Which product codes does it file in?

What has FDA decided for it lately?