FDA applicant

Osspray, Ltd.

Gainesville, FL2 decisions2010–20110 recalls

FDA records 2 decisions for Osspray, Ltd. (Gainesville, FL) from 2010 to 2011: 2 510(k) clearances. Most are in product codes EFB (Handpiece, Air-Powered, Dental) and EJR (Agent, Polishing, Abrasive, Oral Cavity). Its devices cite 4 predicates, 0 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 Osspray, Ltd.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2011

2010high 1 (2010) · low 0 (2012)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2010.

FIG. 1 — Osspray, Ltd. by year, 2010–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Osspray, Ltd.

Which product codes does it file in?

Whose devices does it build on?

What has FDA decided for it lately?