Vivid Aligners
Aligner, Sequential
Orthodent Laboratory, Inc.
The following data is part of a premarket notification filed by Orthodent Laboratory, Inc. with the FDA for Vivid Aligners.
Pre-market Notification Details
| Device ID | K190003 |
| 510k Number | K190003 |
| Device Name: | Vivid Aligners |
| Classification | Aligner, Sequential |
| Applicant | Orthodent Laboratory, Inc. 6325 Sheridan Drive Buffalo, NY 14221 |
| Contact | Michael Wright |
| Correspondent | Robert O. Dean Compliance Systems International, LLC. 1083 Delaware Ave. Buffalo, NY 14209 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-01-02 |
| Decision Date | 2019-11-06 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860011027201 | K190003 | 000 |
Trademark Results [Vivid Aligners]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 VIVID ALIGNERS 86964420 5085985 Live/Registered |
Orthodent Lab 2016-04-05 |
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