Device Classification Name |
Implant, Endosseous, Orthodontic
More FDA Info for this Device |
510(K) Number |
K161335 |
Device Name |
Implant, Endosseous, Orthodontic |
Applicant |
JEIL MEDICAL CORPORATION
702, 703, 704, 705, 706, 804, 805, 807, 812-HO, 55,
DIGITAL-RO34-GIL, GURO-GU
SEOUL 08378 KR
Other 510(k) Applications for this Company
|
Contact |
SEUNGYOUNG LEE
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 |
05/12/2016 |
Decision Date |
02/23/2017 |
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 |
|