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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 K240038
Device Name Clear Moves Aligners
Applicant
Space Maintainers Laboratories (Sml)
5922 9192 Lurline Ave.
Chatsworth,  CA  91311
Applicant Contact Scott Veis
Correspondent
Devicemc, LLC
1 Bay St.
Rancho Mission Viejo,  CA  92694
Correspondent Contact Na Zhang
Regulation Number872.5470
Classification Product Code
NXC  
Date Received01/05/2024
Decision Date 04/04/2024
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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