The following data is part of a premarket notification filed by Orchestrate 3d with the FDA for Orchestrate 3d.
| Device ID | K181112 |
| 510k Number | K181112 |
| Device Name: | Orchestrate 3D |
| Classification | Orthodontic Software |
| Applicant | Orchestrate 3D 1747 North Riverside Ave Rialto, CA 92376 |
| Contact | Todd Ehrler |
| Correspondent | Bill Jacqmein JCQ Consulting 11218 Zest Court NE Blaine, MN 55449 |
| Product Code | PNN |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-04-27 |
| Decision Date | 2018-11-26 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860008123404 | K181112 | 000 |