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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 K211537
Device Name QuickAligners
Applicant
Oral Image, Inc.
6440 Lusk Blvd., Suite D101
San Diego,  CA  92121
Applicant Contact Vinh Lam
Correspondent
Aclivi, LLC
3250 Brackley Dr.
Ann Abror,  MI  48105
Correspondent Contact Chris Brown
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/18/2021
Decision Date 10/26/2021
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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