Orchestrate 3D— 510(k) K181112

Substantially Equivalent

Orchestrate 3D

FDA 510(k) clearance K181112 for Orchestrate 3D, Substantially Equivalent on 2018-11-26. Applicant: Orchestrate 3D. Device class: 2.

Clearance details

Applicant: Orchestrate 3D
Product code: Code PNN
Device class: Class 2
Regulation: 21 CFR 872.5470
Advisory panel: Dental
Date received: 2018-04-27
Decision date: 2018-11-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rialto, CA, US

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

Recalls naming K181112

K-number listed on FDA's recall record

Z-0334-2022 — O3D ORCHESTRATE Orthodontic Technologies User Manual and Data Processing Instructions (model preparation for tooth movement) MKT-LB-002 Rev 1 for Orchestrate3d Software v.3.1 - v5.0.4Class II·Terminated·Orchestrate Orthodontic Technologies, Inc.·20211111

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K181112.

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