3Shape Ortho System— 510(k) K152086

Substantially Equivalent

3Shape A/S

FDA 510(k) clearance K152086 for 3Shape Ortho System, Substantially Equivalent on 2016-04-28. Applicant: 3Shape A/S. Device class: 2.

Clearance details

Applicant: 3Shape A/S
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2015-07-27
Decision date: 2016-04-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Copenhagen, DK

Download summary PDF View on FDA.gov ↗

Recent devices under product code PNN

K260419 — LingOral Dental Design System2026-05-08
K253565 — SureSmile Software2026-03-04
K252507 — SmileInspector2026-01-07
K253343 — Celebrace Software2025-12-29
K250198 — Laon Ortho2025-04-23

More clearances from 3Shape A/S

K200100 — Abutment Design2020-10-07
K191911 — 3Shape Splint Design2019-11-27
K180941 — Ortho System2018-10-17
K171634 — Ortho System2018-01-17
K163677 — Ortho System2017-04-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.