510(k) Report

FDA applicant

Angelus Industria DE Productos Odontologicos

Aventura, FL6 decisions2008–20160 recalls

FDA records 6 decisions for Angelus Industria DE Productos Odontologicos (Aventura, FL) from 2008 to 2016: 6 510(k) clearances. Most are in product codes KIF (Resin, Root Canal Filling) and EBI (Resin, Denture, Relining, Repairing, Rebasing). Its devices cite 8 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Angelus Industria DE Productos Odontologicos SA”.

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 Angelus Industria DE Productos Odontologicos’s devices, and how often a recall has named them.

FDA decisions per year

1in 2016

2008: 12012: 12013: 12014: 22016: 1
2008high 2 (2014) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2008.

FIG. 1 — Angelus Industria DE Productos Odontologicos by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Other applicant names beginning “Angelus”

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