Device Classification Name |
X-Ray, Tomography, Computed, Dental
More FDA Info for this Device |
510(K) Number |
K183475 |
Device Name |
X-Ray, Tomography, Computed, Dental |
Applicant |
Osstem Implant Co., Ltd.
2 Floor, B-dong, 51, Mayu-ro 238beon-gil
Siheung-si 15079 KR
Other 510(k) Applications for this Company
|
Contact |
Jiyoon Ha
Other 510(k) Applications for this Contact |
Regulation Number |
892.1750
More FDA Info for this Regulation Number |
Classification Product Code |
OAS
Other 510(k) Applications for this Device
More FDA Info for this Product Code |
Date Received |
12/17/2018 |
Decision Date |
08/30/2019 |
Decision |
SESE - SUBST EQUIV |
Classification Advisory Committee |
RA - Radiology |
Review Advisory Committee |
RA - Radiology |
Statement / Summary / Purged Status |
Summary |
Type |
Traditional |
Reviewed By Third Party |
N |
Expedited Review |
|