The following data is part of a premarket notification filed by Dentium Co., Ltd with the FDA for Ictmotor (wl-1).
| Device ID | K193341 |
| 510k Number | K193341 |
| Device Name: | ICTmotor (WL-1) |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | Dentium Co., Ltd 76, Changnyong-daero 256beon-gil, Yeongtong-gu Suwon-si, KR 16229 |
| Contact | Sangwoo Lee |
| Correspondent | Dave Kim Mtech Group 7707 Fannin St. Ste 200, V111 Houston, TX 77054 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-12-03 |
| Decision Date | 2020-09-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08809460309843 | K193341 | 000 |