Device Classification Name |
Activator, Ultraviolet, For Polymerization
|
510(k) Number |
K161855 |
Device Name |
LED Curing Light |
Applicant |
MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. |
NEW TAIPEI CITY,
TW
241-58
|
|
Applicant Contact |
SHU-LUNG WANG |
Correspondent |
MONITEX INDUSTRIAL CO., LTD. |
6F, 70 SEC. 1 GUANG-FU ROAD, SANCHONG DIST. |
NEW TAIPEI CITY,
TW
241-58
|
|
Correspondent Contact |
SHU-LUNG WANG |
Regulation Number | 872.6070
|
Classification Product Code |
|
Date Received | 07/06/2016 |
Decision Date | 11/27/2017 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|