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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 K250487
Device Name SparkTM Clear Aligner System
Applicant
Ormco Corporation
200 S. Kraemer Blvd.
Brea,  CA  92821
Applicant Contact Jessica Pomares
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact Prithul Bom
Regulation Number872.5470
Classification Product Code
NXC  
Date Received02/19/2025
Decision Date 02/20/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Dental
510k Review Panel Dental
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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