FDA 510(k) Application Details - K243370

Device Classification Name	Crown And Bridge, Temporary, Resin   More FDA Info for this Device
510(K) Number	K243370
Device Name	Crown And Bridge, Temporary, Resin
Applicant	Asiga Pty Ltd Unit 2, 19-21 Bourke Road Alexandria 2015 AU Other 510(k) Applications for this Company
Contact	Justin Elsey 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	10/30/2024
Decision Date	05/05/2025
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