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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 K241137
Device Name Clear Moves Aligner
Applicant
Clear Moves Aligners
100 Jade Block, Park View
River Edge Housing Scheme
Lahore,  PK 54000
Applicant Contact Awais Muhammad
Correspondent
Trisler Consulting
306 Turnberry Ct.
Lebanon,  IN  46052
Correspondent Contact Patsy Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received04/24/2024
Decision Date 08/01/2024
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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