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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Aligner, Sequential
510(k) Number K220835
Device Name Arkligners
Applicant
Arklign Laboratories
2526 Qume Dr.
Suite 15
San Jose,  CA  95131
Applicant Contact Rex Ho
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,,  OR  97030 -0172
Correspondent Contact Angela Blackwell
Regulation Number872.5470
Classification Product Code
NXC  
Date Received03/22/2022
Decision Date 08/12/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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