510(k) Report

FDA applicant

Alliage S/A Industrias Medico Odontológica

Recreio Anhanguera, BR3 decisions2021–20240 recalls

FDA records 3 decisions for Alliage S/A Industrias Medico Odontológica (Recreio Anhanguera, BR) from 2021 to 2024: 3 510(k) clearances. Most are in product codes OAS (X-Ray, Tomography, Computed, Dental) and EHD (Unit, X-Ray, Extraoral With Timer). Since 2016 its 510(k)s took a median of 108 days from receipt to decision, against 77 for FDA’s reviews in the same codes and years. Its devices cite 3 predicates, 1 of them its own earlier devices. No recall is linked to its devices.

FDA’s records also spell it “Alliage S/A Industrias Médico Odontológica”.

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

FIG. A — Illustration, radiology panel, where it files most

How often FDA has decided Alliage S/A Industrias Medico Odontológica’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2021: 12023: 12024: 1
2021high 1 (2021) · low 0 (2022)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2021.

FIG. 1 — Alliage S/A Industrias Medico Odontológica by year, 2021–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • OASX-Ray, Tomography, Computed, Dental2decisions
  • EHDUnit, X-Ray, Extraoral With Timer1decision

How long do its 510(k) reviews take?

Since 2016, its 3 510(k)s took a median of 108 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 77 days; 0 of its 3 were faster than that.

Whose devices does it build on?

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

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 20211cites it

What has FDA decided for it lately?

  • K233395Portable Dental X-Ray (AXR60 S); Portable Dental X-Ray (AXR65 S)Alliage S/A Industrias Médico Odontológica · 2024
  • K223816Dental CT Scanner AXRAlliage S/A Industrias Medico Odontológica · 2023
  • K210820EAGLE EDGE AXR90 and AXR120Alliage S/A Industrias Medico Odontológica · 2021

All 2 as Alliage S/A Industrias Medico Odontológica →The one decision as Alliage S/A Industrias Médico Odontológica →

Other applicant names beginning “Alliage”

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

Alliage S/A Industrias Medica Odontológico. 1