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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 K213297
Device Name Redline
Applicant
Johns Dental Laboratories
423 S. 13th ST
Terre Haute,  IN  47807
Applicant Contact Marni Buis
Correspondent
Evo820, LLC
1 Bay Street
Rancho Mission Viejo,  CA  92694
Correspondent Contact Na Zhang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received10/01/2021
Decision Date 02/09/2022
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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