Device Classification Name |
activator, ultraviolet, for polymerization
|
510(k) Number |
K220826 |
Device Name |
LED Curing Light |
Applicant |
Foshan COXO Medical Instrument Co., Ltd. |
BLDG 4, District A, Guangdong New Light Source Industrial |
Base, South of Luocun Avenue |
Nanhai District, Foshan,
CN
528226
|
|
Applicant Contact |
Yongjian Zheng |
Correspondent |
Beijing Believe-Med Technology Service Co., Ltd. |
Rm.912, Building #15, XiYueHui, No.5, YiHe North Rd., |
FangShan District |
Beijing,
CN
102401
|
|
Correspondent Contact |
Ray Wang |
Regulation Number | 872.6070
|
Classification Product Code |
|
Date Received | 03/22/2022 |
Decision Date | 12/08/2022 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|