The following data is part of a premarket notification filed by Smylio, Inc with the FDA for Smylic Invisible Clear Aligners.
| Device ID | K173784 |
| 510k Number | K173784 |
| Device Name: | Smylic Invisible Clear Aligners |
| Classification | Aligner, Sequential |
| Applicant | Smylio, Inc 48890 Milmont Drive Fremont, CA 94538 |
| Contact | Ken Menon |
| Correspondent | Bill Jacqmein JCQ Consulting 11218 Zest Court NE Blaine, MN 55449 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-12-13 |
| Decision Date | 2018-08-23 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 18600033217063 | K173784 | 000 |
| 00860003321706 | K173784 | 000 |
| 00860003321751 | K173784 | 000 |