The following data is part of a premarket notification filed by Arklign Laboratories with the FDA for Arkligners.
| Device ID | K220835 |
| 510k Number | K220835 |
| Device Name: | Arkligners |
| Classification | Aligner, Sequential |
| Applicant | Arklign Laboratories 2526 Qume Dr Suite 15 San Jose, CA 95131 |
| Contact | Rex Ho |
| Correspondent | Angela Blackwell Blackwell Device Consulting P.O. Box 718 Gresham, OR 97030 -0172 |
| Product Code | NXC |
| CFR Regulation Number | 872.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2022-03-22 |
| Decision Date | 2022-08-12 |