510(k) Report

FDA applicant

Produits Dentaires Pierre Rolland (Acteon Group)

Merignac, FR1 decision2015–20150 recalls

FDA records 1 decision for Produits Dentaires Pierre Rolland (Acteon Group) (Merignac, FR) in 2015: 1 510(k) clearance. All are in product code MVL (Cord, Retraction). No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

How often FDA has decided Produits Dentaires Pierre Rolland (Acteon Group)’s devices, and how often a recall has named them.

FDA decisions per year

1in 2015

2015: 1
2015high 1 (2015) · low 0 (2016)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2015.

FIG. 1 — Produits Dentaires Pierre Rolland (Acteon Group) by year, 2015–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Produits”

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