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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 K242715
Device Name Pearl Clear Aligner
Applicant
Pearl Digital, Inc.
2975 Scott Blvd., Suite 110
Santa Clara,  CA  95054
Applicant Contact Henry Cao
Correspondent
Pearl Digital, Inc.
2975 Scott Blvd., Suite 110
Santa Clara,  CA  95054
Correspondent Contact Patsy Trisler
Regulation Number872.5470
Classification Product Code
NXC  
Date Received09/10/2024
Decision Date 01/16/2025
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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