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 | K192596 |
| 510k Number | K192596 |
| Device Name: | ULab Systems Dental Aligner Kit |
| Classification | Aligner, Sequential |
| Applicant | uLab Systems, Inc. 6 Lagoon Drive, Suite 180 Redwood City, CA 94065 |
| Contact | Charlie Wen |
| 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 | 2019-09-20 |
| Decision Date | 2020-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860002380056 | K192596 | 000 |
| 00860002380063 | K192596 | 000 |