K201192 is an FDA 510(k) clearance for the Impla-NX (Model: ISE-270M). This device is classified as a Controller, Foot, Handpiece And Cord (Class I - General Controls, product code EBW).
Submitted by Micro-Nx Co., Ltd. (Daegu, KR). The FDA issued a Cleared decision on May 21, 2021, 382 days after receiving the submission on May 4, 2020.
This device falls under the Dental FDA review panel. Regulated under 21 CFR 872.4200.
| 510(k) Number | K201192 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 04, 2020 |
| Decision Date | May 21, 2021 |
| Days to Decision | 382 days |
| Submission Type | Traditional |
| Review Panel | Dental (DE) |
| Summary | Summary PDF |
| Product Code | EBW - Controller, Foot, Handpiece And Cord |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 872.4200 |