510(k) Report

FDA applicant

Exocad GmbH

Darmstadt, DE3 decisions2019–20221 recall

FDA records 3 decisions for Exocad GmbH (Darmstadt, DE) from 2019 to 2022: 3 510(k) clearances. Most are in product codes LLZ (System, Image Processing, Radiological) and PNP (Dental Abutment Design Software For Dental…). Its devices cite 3 predicates, 1 of them its own earlier devices. 1 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, radiology panel, where it files most

How often FDA has decided Exocad GmbH’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2019: 12021: 12022: 1
2019high 1 (2019) · low 0 (2020)2026

2026 so far, outlined.

Recalls per year

1in 2023

2023: 1
2019high 1 (2023) · low 0 (2019)2026

Class I Class II/III not classified

FIG. 1 — Exocad GmbH by year, 2019–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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Which product codes does it file in?

  • LLZSystem, Image Processing, Radiological2decisions
  • PNPDental Abutment Design Software For Dental Laboratory1decision

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.

  • K183458exoplan 2.3Exocad GmbH · 20191cites it

What has FDA decided for it lately?

  • K213302exoplanExocad GmbH · 20221 recall
  • K193352AbutmentCADExocad GmbH · 2021
  • K183458exoplan 2.3Exocad GmbH · 2019

All 3 as Exocad GmbH →

What has been recalled?

1 recall linked to its devices; the latest:

  • K213302exoplan version 3.1 Rijeka Software -A medical software, intended to support the…Aug 17, 2023Class II