The following data is part of a premarket notification filed by Smylio, Inc with the FDA for Smylio Invisible Clear Aligners.
| Device ID | K212660 |
| 510k Number | K212660 |
| Device Name: | Smylio Invisible Clear Aligners |
| Classification | Aligner, Sequential |
| Applicant | Smylio, Inc 48890 Milmont Dr. Fremont, CA 94538 |
| Contact | Ren Menon |
| Correspondent | Breanne Butler Prime Path Medtech 1321 Upland Dr. Suite 6792 Houston, TX 77043 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2021-08-23 |
| Decision Date | 2021-09-22 |