FDA applicant

Spelna, Inc.

Fredericksburg, VA11 decisions1982–19860 recalls

FDA records 11 decisions for Spelna, Inc. (Fredericksburg, VA) from 1982 to 1986: 11 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and EIA (Unit, Operative 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 Spelna, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

No FDA decision for Spelna, Inc. since 2007.

Recalls per year

No recall linked to its devices since 2007.

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

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Spelna, Inc.

Which product codes does it file in?

What has FDA decided for it lately?