FDA 510(k) Application Details - K243255

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K243255
Device Name	Implant, Endosseous, Root-Form
Applicant	TruAbutment Inc. 17666 Fitch Irvine, CA 92614 US Other 510(k) Applications for this Company
Contact	Ki Yoon Nam Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	DZE Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/15/2024
Decision Date	07/03/2025
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