FDA 510(k) Application Details - K242897

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K242897
Device Name	Resin, Denture, Relining, Repairing, Rebasing
Applicant	Clemde Sa De Cv Av La Fortuna 136 Mexico City 07800 MX Other 510(k) Applications for this Company
Contact	Cabrera Francisco Other 510(k) Applications for this Contact
Regulation Number	872.3760   More FDA Info for this Regulation Number
Classification Product Code	EBI Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/23/2024
Decision Date	06/03/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review