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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 -5922
Applicant Contact Scott Veis
Correspondent
DeviceMC LLC.
1 Bay Street
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
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