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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Resin, Denture, Relining, Repairing, Rebasing
510(k) Number K242897
Device Name Partial Flex
Applicant
Clemde SA DE CV
Av La Fortuna 136
Mexico City,  MX 07800
Applicant Contact Cabrera Francisco
Correspondent
Clemde SA DE CV
Av La Fortuna 136
Mexico City,  MX 07800
Correspondent Contact Cabrera Francisco
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Code
MQC  
Date Received09/23/2024
Decision Date 06/03/2025
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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