3Shape Ortho System

United States

Model 2015-1 · 3shape A/S

3Shape’s Ortho System™ is a software system used for the management of 3D scanned orthodontic models of the patients, orthodontic diagnosis by measuring, analyzing, inspecting and visualize 3D scanned orthodontic models, virtual planning of orthodontic treatments by simulating tooth movements, virtual placement of orthodontic brackets on the 3D models and design of orthodontic appliances based on 3D scanned orthodontic models, including transfer methods for indirect bonding of brackets. Output includes only Export Model (also called dental casts), Custom Metal Bands (also called metal bands), and Indirect Bonding Transfer Trays (also called orthodontic bracket placement trays). All devices are to be fabricated from FDA cleared materials.

DI: 05902768365283
Device class: Class II
Product codes
Submissions: K152086

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Adverse-event reports (MAUDE)

Read this first: 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 shows reporting volume for the average device in the same FDA product code — a reporting baseline, not a risk measure.

No adverse-event reports are linked to this device.

Recall history

No recalls linked.

Regulatory clearances

510(k)K152086Substantially equivalent (SESE) · 2016-04-28clearance family

Predicate lineage

K152086
- K082207
- K110430

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 each submission cites, walked transitively (indented = the cited device's own predicates). Extracted from public 510(k) summary text — heuristic, and includes reference devices mentioned alongside true predicates.

Manufacturer compliance record

Date	Type	Outcome	Facility	Citations
2025-04-09	NAI	No action indicated	3Shape Inc.	0
2015-10-08	NAI	No action indicated	3shape inc.	0
2013-09-26	VAI	Voluntary action indicated	3Shape Poland	1
2012-02-09	VAI	Voluntary action indicated	3Shape A/S	4
2012-02-09	VAI	Voluntary action indicated	3Shape A/S	4

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