FDA 510(k) Application Details - K211992

Device Classification Name	Implant, Endosseous, Orthodontic   More FDA Info for this Device
510(K) Number	K211992
Device Name	Implant, Endosseous, Orthodontic
Applicant	Osteonic Co., Ltd. 303Ho, 405Ho, 505-2Ho, 505-3Ho, 902Ho, 1004Ho, 1201Ho 1202Ho, 1206Ho, 38 Digital-ro 29-gil Guro-gu 08381 KR Other 510(k) Applications for this Company
Contact	Lee Jisun 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	06/28/2021
Decision Date	10/15/2021
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