FDA 510(k) Application Details - K192218

Device Classification Name	Abutment, Implant, Dental, Endosseous   More FDA Info for this Device
510(K) Number	K192218
Device Name	Abutment, Implant, Dental, Endosseous
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	872.3630   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	08/15/2019
Decision Date	05/08/2020
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