3Shape Ortho System
Model 2015-1 · 3shape A/S · DI 05902768365283
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.
| Month | This device (reports) | Product-code average (reports per device) |
|---|---|---|
| 2022-01 | 0 | 1 |
| 2022-11 | 0 | 1 |
| 2022-12 | 0 | 1 |
| 2023-02 | 0 | 1 |
Regulatory clearances
- K152086 SESE 2016-04-28 (k number procode)
Predicate lineage
K152086 — cites (transitively): K082207 (d1), K110430 (d1) — cited as predicate by K163677, K171122, K171295, K171634, K173785, K180241, K182329, K182658, K183643, K190003, K191774, K192338, K192470, K192701, K200772, K203339, K210373, K210763, K211010, K212173, K212772, K212803, K222418, K232429, K232549, K242929, K260722
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