U-Aligner
Aligner, Sequential
Universal Orthodontic Laboratory Inc
The following data is part of a premarket notification filed by Universal Orthodontic Laboratory Inc with the FDA for U-aligner.
Pre-market Notification Details
| Device ID | K191308 |
| 510k Number | K191308 |
| Device Name: | U-Aligner |
| Classification | Aligner, Sequential |
| Applicant | Universal Orthodontic Laboratory Inc 11917 Front St. Norwalk, CA 90650 |
| Contact | Jiahe Li |
| Correspondent | Jiahe Li Universal Orthodontic Laboratory Inc 11917 Front St. Norwalk, CA 90650 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-14 |
| Decision Date | 2020-04-23 |
Trademark Results [U-Aligner]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 U-ALIGNER 88091613 not registered Live/Pending |
UNIVERSAL ORTHODONTIC LAB, INC. 2018-08-24 |
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