FDA 510(k) Application Details - K231859

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K231859
Device Name	Crown And Bridge, Temporary, Resin
Applicant	DentsCare LTDA Av. Edgar Nelson Meister, 474 Joinville 89219-501 BR Other 510(k) Applications for this Company
Contact	Roberta Uyara 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	06/23/2023
Decision Date	11/26/2024
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