Device Classification Name |
System, Image Processing, Radiological
|
510(k) Number |
K183676 |
Device Name |
DentiqAir |
Applicant |
3D Industrial Imaging Co., Ltd. |
Bldg.138, Rm.413, Seoul National University |
1 Gwanak-ro |
Seoul,
KR
0882
|
|
Applicant Contact |
Bora Choi |
Correspondent |
Wise Company Inc. |
#1005, 11-19, Gamasan-ro 27a-gil |
Guro-gu,
KR
08301
|
|
Correspondent Contact |
Sanglok Lee |
Regulation Number | 892.2050
|
Classification Product Code |
|
Date Received | 12/28/2018 |
Decision Date | 12/19/2019 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Radiology
|
510k Review Panel |
Radiology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|