510(k) K181112 ยท PNN Orthodontic Software
Orchestrate 3D
| Applicant | Orchestrate 3D, Rialto CA, US |
| Decision | Substantially Equivalent, Nov 26, 2018 |
| Received | Apr 27, 2018 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K181112
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 11, 2021 | Orchestrate Orthodontic Technologies, Inc. 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 Terminated |
PNN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.