The following data is part of a premarket notification filed by Ulab Systems, Inc. with the FDA for Ulab Systems Dental Aligner Kit.
| Device ID | K211510 |
| 510k Number | K211510 |
| Device Name: | ULab Systems Dental Aligner Kit |
| Classification | Aligner, Sequential |
| Applicant | uLab Systems, Inc. 1820 Gateway Drive, Suite 300 San Mateo, CA 94404 |
| Contact | Amir Albolfathi |
| Correspondent | Sylvia Erickson Sylvia Erickson Consulting 157 Ruby Avenue San Carlos, CA 94070 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-05-14 |
| Decision Date | 2022-02-24 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002380094 | K211510 | 000 |