FDA 510(k) Application Details - K243356

Device Classification Name	Resin, Denture, Relining, Repairing, Rebasing   More FDA Info for this Device
510(K) Number	K243356
Device Name	Resin, Denture, Relining, Repairing, Rebasing
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	872.3760   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	10/29/2024
Decision Date	04/11/2025
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Abbreviated
Reviewed By Third Party	N
Expedited Review