FDA applicant

Satelec - Acteon Group

Mt. Laurel, NJ11 decisions2007–20240 recalls

FDA records 11 decisions for Satelec - Acteon Group (Mt. Laurel, NJ) from 2007 to 2024: 11 510(k) clearances. Most are in product codes ELC (Scaler, Ultrasonic) and DZI (Drill, Bone, Powered). Its devices cite 17 predicates, 6 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 Satelec - Acteon Group’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2007high 4 (2014) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

Planning a device like Satelec - Acteon Group’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

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Other applicant names beginning “Satelec”

FDA records each applicant name separately; these may or may not be the same firm.

Satelec 24 Satelec - Acteon, Inc. 1

Satelec - Acteon Group

Which product codes does it file in?

Whose devices does it build on?

Who builds on its devices?

Which of its devices are cited most?

What has FDA decided for it lately?

Other applicant names beginning “Satelec”