FDA 510(k) Application Details - K233083

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K233083
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	Implant Solutions PTY LTD (aka Osteon Medical) 759-767 Springvale Road Mulgrave 3170 AU Other 510(k) Applications for this Company
Contact	Farah Rahman Other 510(k) Applications for this Contact
Regulation Number	872.3630   More FDA Info for this Regulation Number
Classification Product Code	NHA Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	09/26/2023
Decision Date	03/09/2024
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