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3SHAPE ORTHO SYSTEM

3SHAPE A/S

UDILibrary device dossier · generated 2026-09-14 · sources: FDA GUDID, openFDA (recalls, MAUDE, 510(k)/PMA), FDA Data Dashboard (inspections, compliance actions), 510(k) summary documents.

Recall history (0)

No recalls linked in the loaded window.

Adverse-event reports — MAUDE (0)

Caveat (required reading): MAUDE report counts cannot be used to compute incidence rates or compare device safety. Reporting is incomplete, duplicated, and spikes with publicity; there is no denominator of devices in use. The peer line is a reporting baseline (average device in the same product code), not a risk measure.

No dated reports to chart.

Regulatory clearances

  • None linked in the loaded window.

Manufacturer compliance record — 3SHAPE A/S

  • NAI 2025-04-09 3Shape Inc. · 0 citations
  • NAI 2015-10-08 3shape inc. · 0 citations
  • VAI 2013-09-26 3Shape Poland · 1 citations
  • VAI 2012-02-09 3Shape A/S · 4 citations
  • VAI 2012-02-09 3Shape A/S · 4 citations