FDA 510(k) Application Details - K243621

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K243621
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Evoden Ind·stria ComΘrcio Importaτπo e Exportaτπo de Produtos Odontol≤gicos Ltda. R: GenΘsio de Bem, 1634 Distrito Industrial Pirassununga 13633-428 BR Other 510(k) Applications for this Company
Contact	JΘssica Augusto Other 510(k) Applications for this Contact
Regulation Number	872.3770   More FDA Info for this Regulation Number
Classification Product Code	EBG Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/22/2024
Decision Date	04/22/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review