FDA 510(k) Application Details - K183242

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K183242
Device Name	Implant, Endosseous, Root-Form
Applicant	Hiossen, Inc. 85 Ben Fairless Drive Fairless Hills, PA 19030 US Other 510(k) Applications for this Company
Contact	Peter Lee 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	11/21/2018
Decision Date	05/21/2019
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review