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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 K191308
Device Name U-Aligner
Applicant
Universal Orthodontic Laboratory, Inc.
11917 Front St.
Norwalk,  CA  90650
Applicant Contact Jiahe Li
Correspondent
Universal Orthodontic Laboratory, Inc.
11917 Front St.
Norwalk,  CA  90650
Correspondent Contact Jiahe Li
Regulation Number872.5470
Classification Product Code
NXC  
Date Received05/14/2019
Decision Date 04/23/2020
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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