Device Classification Name |
activator, ultraviolet, for polymerization
|
510(k) Number |
K192233 |
Device Name |
LED Curing Light |
Applicant |
Foshan CICADA Dental Instrument Co., Ltd. |
B5-2F, Guangdong New Light Source Industrial Base |
Shihan Town, Nanhai |
Foshan,
CN
|
|
Applicant Contact |
Juan Liu |
Correspondent |
KEDA Biological Technology Co., Ltd. |
6F, No.1 TianTai road, Science City, LuoGang District |
Guangzhou,
CN
|
|
Correspondent Contact |
Jet Li |
Regulation Number | 872.6070
|
Classification Product Code |
|
Date Received | 08/19/2019 |
Decision Date | 02/13/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|