510(k) Report

FDA applicant

Produits Dentaires Pierre Rolland

Orange, CA2 decisions2005–20110 recalls

FDA records 2 decisions for Produits Dentaires Pierre Rolland (Orange, CA) from 2005 to 2011: 2 510(k) clearances. All are in product code MVL (Cord, Retraction). Its devices cite 3 predicates, 1 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

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

FDA decisions per year

1in 2011

2011: 1
2007high 1 (2011) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Which product codes does it file in?

  • MVLCord, Retraction2decisions

Whose devices does it build on?

Its devices cite 3 predicates; 1 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 7 times; 1 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K050180Expa-SylProduits Dentaires Pierre Rolland · 20057cite it

What has FDA decided for it lately?

  • K111978Sulcus BlueProduits Dentaires Pierre Rolland · 2011
  • K050180Expa-SylProduits Dentaires Pierre Rolland · 2005

All 2 as Produits Dentaires Pierre Rolland →

Other applicant names beginning “Produits”

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

Produits Dentaires Pierre Rolland (Acteon Group) 1