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 |