The following data is part of a premarket notification filed by Orthodent Laboratory, Inc. with the FDA for Vivid Aligners.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00860011027201 | K190003 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
VIVID ALIGNERS 86964420 5085985 Live/Registered |
Orthodent Lab 2016-04-05 |