Device Classification Name |
activator, ultraviolet, for polymerization
|
510(k) Number |
K191221 |
Device Name |
Cybird LED Curing Light |
Applicant |
DXM Co., Ltd |
Baekseok-dong, Ilsan technotown 1003, 138, Ilsan-ro, |
Ilsandong-gu |
Goyang-si,
KR
411-360
|
|
Applicant Contact |
Seung Hyun Kim |
Correspondent |
Mtech Group |
8310 Buffalo Speedway |
Houston,
TX
77025
|
|
Correspondent Contact |
Dave Kim |
Regulation Number | 872.6070
|
Classification Product Code |
|
Date Received | 05/07/2019 |
Decision Date | 01/10/2020 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Dental
|
510k Review Panel |
Dental
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|