The following data is part of a premarket notification filed by Motor City Lab Works with the FDA for Clearform Aligners.
| Device ID | K191838 |
| 510k Number | K191838 |
| Device Name: | Clearform Aligners |
| Classification | Aligner, Sequential |
| Applicant | Motor City Lab Works 2200 Holland Street Birmingham, MI 48009 |
| Contact | Christina Groth |
| Correspondent | Chris Brown Aclivi, LLC 6455 Farley Road Pinckney, MI 48169 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-07-09 |
| Decision Date | 2020-03-20 |