FDA 510(k) Application Details - K213576

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K213576
Device Name	Implant, Endosseous, Root-Form
Applicant	Suncoast Dental, Inc. dba Tatum Surgical 4500 140th Avenue North Suite 112 Clearwater, FL 33762 US Other 510(k) Applications for this Company
Contact	Tony Fiorello 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	11/10/2021
Decision Date	07/15/2022
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