The following data is part of a premarket notification filed by Key Dental Technologies, Llc with the FDA for Myclearalign Dental Aligner System.
| Device ID | K221475 |
| 510k Number | K221475 |
| Device Name: | MyClearALIGN Dental Aligner System |
| Classification | Aligner, Sequential |
| Applicant | Key Dental Technologies, LLC 920 MLK Blvd Suite 920-B Chapel Hill, NC 27517 |
| Contact | Larry Moray |
| Correspondent | Thomas Padula Schiff & Company, Inc. 583 Mountain Avenue North Caldwell, NJ 07006 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-05-20 |
| Decision Date | 2022-08-31 |