FDA 510(k) Application Details - K243094

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K243094
Device Name	Implant, Endosseous, Root-Form
Applicant	Quickdent Devices Private Ltd. Unit No. 128, Kuber Complex New Link Rd S N of Village Oshwari Link Rd, Adheri West, Mumbai, Mumbai Surburban 400053 IN Other 510(k) Applications for this Company
Contact	Mayur Khairnar 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	09/30/2024
Decision Date	12/19/2024
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