FDA 510(k) Application Details - K222211

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K222211
Device Name	Implant, Endosseous, Root-Form
Applicant	Implant Direct Sybron Manufacturing LLC 3050 East Hillcrest Drive Thousand Oaks, CA 91362 US Other 510(k) Applications for this Company
Contact	Reina Choi 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	07/25/2022
Decision Date	02/02/2023
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	DE - Dental
Review Advisory Committee	DE - Dental
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review