The following data is part of a premarket notification filed by Micro-nx Co., Ltd. with the FDA for Impla-nx (model: Ise-270m).
| Device ID | K201192 |
| 510k Number | K201192 |
| Device Name: | Impla-NX (Model: ISE-270M) |
| Classification | Controller, Foot, Handpiece And Cord |
| Applicant | MICRO-NX Co., Ltd. 37, Dalseong2chadong 3-ro, Guji-myeon, Dalseong-gun Daegu, KR 711-891 |
| Contact | Jong-kun Lee |
| Correspondent | Priscilla Chung LK Consulting Group USA, Inc. 1150 Roosevelt STE 200 Irvine, CA 92620 |
| Product Code | EBW |
| CFR Regulation Number | 872.4200 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-05-04 |
| Decision Date | 2021-05-21 |