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 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ARKLIGNERS 98651084 not registered Live/Pending |
ARKLIGN LABORATORIES, INC. 2024-07-16 |