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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 St. Suite A
Fort Lauderdale,  FL  33308
Applicant Contact Chris Freeman
Correspondent
Evo820, LLC
1 Bay St.
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
Predetermined Change
Control Plan Authorized		 No
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