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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 St.
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
Predetermined Change
Control Plan Authorized		 No
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