The following data is part of a premarket notification filed by Dxm Co., Ltd with the FDA for Cybird Led Curing Light.
Device ID | K191221 |
510k Number | K191221 |
Device Name: | Cybird LED Curing Light |
Classification | Activator, Ultraviolet, For Polymerization |
Applicant | DXM Co., Ltd Baekseok-dong, Ilsan Technotown 1003, 138, Ilsan-ro, Ilsandong-gu Goyang-si, KR 411-360 |
Contact | Seung Hyun Kim |
Correspondent | Dave Kim Mtech Group 8310 Buffalo Speedway Houston, TX 77025 |
Product Code | EBZ |
CFR Regulation Number | 872.6070 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-05-07 |
Decision Date | 2020-01-10 |