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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 K203737
Device Name Spark Clear Aligner System
Applicant
Ormco Corporation
200 S. Kraemer Blvd.
Brea,  CA  92821
Applicant Contact Frank Ray
Correspondent
Ormco Corporation
200 S. Kraemer Blvd.
Brea,  CA  92821
Correspondent Contact Frank Ray
Regulation Number872.5470
Classification Product Code
NXC  
Subsequent Product Code
PNN  
Date Received12/22/2020
Decision Date 03/22/2021
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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