Recall Z-0334-2022— Orchestrate Orthodontic Technologies, Inc.

Name: FDA recall Z-0334-2022
Creator: U.S. Food and Drug Administration
Published: 2021-11-11

Class II · Terminated

Class II FDA medical device recall by Orchestrate Orthodontic Technologies, Inc., initiated 2021-11-11, terminated 2024-01-10. It names one FDA 510(k) clearance: K181112. Product: 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 - v5.0.4. Reason: Due to product label/labeling being altered from it's approved state..

Recalling firm: Orchestrate Orthodontic Technologies, Inc.
Classification: Class II
Status: Terminated
Initiated: 2021-11-11
Terminated: 2024-01-10
Firm location: Rialto, CA, United States

510(k) clearances named in this recall

1 on FDA's record

K181112 — Orchestrate 3DOrchestrate 3D·cleared 2018-11-26

K-numbers as listed on FDA's Recall Enterprise System record for this event (openFDA device/recall k_numbers). The recall may also cover devices cleared under other submissions not named here.

Product description

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 - v5.0.4

Reason for recall

Due to product label/labeling being altered from it's approved state.

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