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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 K212772
Device Name Precision Align
Applicant
Precision Align LLC.
1825 NE 45th Street Suite A
Fort Lauderdale,  FL  33308
Applicant Contact Chris Freeman
Correspondent
evo820, LLC
1 Bay Street
Rancho Mission Viejo,  CA  92694
Correspondent Contact Na Zhang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received08/31/2021
Decision Date 01/15/2022
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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