FDA 510(k) Application Details - K202163

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K202163
Device Name	Implant, Endosseous, Orthodontic
Applicant	Ze Fang Technology Co., Ltd. No.17, Aly. 81, Ln. 2, Sec. 1, Zhongxing Rd., Dali Dist., Taichung City, Taiwan Taichung 412 TW Other 510(k) Applications for this Company
Contact	Anita Chen Other 510(k) Applications for this Contact
Regulation Number	872.3640   More FDA Info for this Regulation Number
Classification Product Code	OAT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/03/2020
Decision Date	10/07/2022
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