FDA 510(k) Application Details - K221315

Device Classification Name	Implant, Endosseous, Root-Form   More FDA Info for this Device
510(K) Number	K221315
Device Name	Implant, Endosseous, Root-Form
Applicant	UNIdental Co., Ltd. #D-613 GM Techno-park, 60 Haan-ro Gwangmyeong-si 14322 KR Other 510(k) Applications for this Company
Contact	Nam Kyu Kang 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	05/06/2022
Decision Date	10/25/2023
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