ELEC ENGINE (Model: ISE-170L)
FDA 510(k) K231562 · Micro-Nx Co., Ltd.
510(k) numberK231562
Submission
- Device name
- ELEC ENGINE (Model: ISE-170L)
- Applicant
- Micro-Nx Co., Ltd.
Daegu, KR - Received
- May 31, 2023
- Decision date
- July 18, 2025
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 510(k)
- Summary
- 510(k) summary available from FDA
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| 510(k) | Device | Decision |
|---|---|---|
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoitEKX · Traditional | 11/09/2023SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | 07/29/2022SE |
| K201191 | Elec-LedEBW · Traditional | 02/07/2022SE |
| K201192 | Impla-NX (Model: ISE-270M)EBW · Traditional | 05/21/2021SE |
| K192809 | Dental HandpieceEFA · Traditional | 08/25/2020SE |
| K161500 | Meg-TorqEKX · Traditional | 02/22/2017SE |
Questions and answers
When was ELEC ENGINE (Model: ISE-170L) cleared by the FDA?
ELEC ENGINE (Model: ISE-170L) (K231562) received a 510(k) decision of Substantially Equivalent on July 18, 2025, 779 days after the submission was received.
What is the product code of K231562?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.