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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 K233171
Device Name PF Keep; Cad Cam Keep Block
Applicant
Clemde SA DE CV
Av La Fortuna 136
Mexico City,  MX 07800
Applicant Contact Francisco Cabrera
Correspondent
Clemde SA DE CV
Av La Fortuna 136
Mexico City,  MX 07800
Correspondent Contact Francisco Cabrera
Regulation Number872.3760
Classification Product Code
EBI  
Subsequent Product Codes
EBF   EBG  
Date Received09/28/2023
Decision Date 11/27/2023
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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