FDA 510(k) Application Details - K171532

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K171532
Device Name	Abutment, Implant, Dental, Endosseous
Applicant	TruAbutment Inc. 300 South Harbor Blvd #520 Anaheim, CA 92805 US Other 510(k) Applications for this Company
Contact	Brandon Kim 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	05/25/2017
Decision Date	09/11/2018
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