510(k) Report

FDA applicant

Endo Twinn B.V.

Amsterdam, NL2 decisions2005–20070 recalls

FDA records 2 decisions for Endo Twinn B.V. (Amsterdam, NL) from 2005 to 2007: 2 510(k) clearances. All are in product code EKM (Gutta-Percha). Its devices cite 2 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 Endo Twinn B.V.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2007

2007: 1
2007high 1 (2007) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

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

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Other applicant names beginning “Endo”

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