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Splint Design

Model R1.0 · 3shape A/S · DI 05902729753555

PNN — Orthodontic Software · Class II · 21 CFR 872.5470

UDILibrary device dossier · generated 2026-09-15 · 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.

01112022-01: 0 reports for this device; peer average 1/device2022-11: 0 reports for this device; peer average 1/device2022-12: 0 reports for this device; peer average 1/device2023-02: 0 reports for this device; peer average 1/device01111202
Monthly adverse-event reports for this device versus the product-code average.
MonthThis device (reports)Product-code average (reports per device)
2022-0101
2022-1101
2022-1201
2023-0201
This device (reports/month)Average device in PNN (reports/device/month)

Regulatory clearances

  • K191911 SESE 2019-11-27 (k number procode)

Predicate lineage

K191911 — cites (transitively): K161884 (d1)

Lineage extracted from public 510(k) summary text (heuristic).

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