Elec Engine (Model: ISE-170L)
FDA 510(k)EUDAMEDClass I (US FDA 510(k))
Identifiers
- 510(k) Number
- K231562 FDA 510(k)
- FDA Product Code
- EBW FDA 510(k)
Classification
- Device Class
- Class I FDA 510(k)
- Legislation / Framework
- 21 CFR Part 872.4200 FDA 510(k)
- Regulation Number
- 872.4200 FDA 510(k)
- Advisory Committee
- Dental FDA 510(k)
- FDA Decision
- SESE Substantially Equivalent FDA 510(k)
The ELEC ENGINE (Model: ISE-170L) is a Class 1 dental device classified as a Controller, Foot, Handpiece And Cord. It is manufactured by Micro-Nx Co., Ltd. and is designed for dental applications.
The device is supplied as a single unit and is cleared through the Special 510(k) pathway with FDA clearance number K231562. It is regulated under product code EBW and regulation number 872.4200, with a decision date of 2025-07-18.
Frequently asked questions
What type of dental device is the ELEC ENGINE ISE-170L?
It is classified as a Class 1 Controller, Foot, Handpiece and Cord for dental use, meaning it performs basic control functions without requiring extensive pre‑market testing.
How is the ELEC ENGINE ISE-170L supplied and is it reusable?
The device is provided as a single unit. As a Class 1 controller, it is intended for repeated clinical use rather than a single‑use disposable product, provided it is maintained according to the manufacturer’s guidelines.
What regulatory clearance does the ELEC ENGINE ISE-170L have?
It received FDA clearance through the Special 510(k) pathway (clearance number K231562) on 2025‑07‑18, indicating it is substantially equivalent to a legally marketed predicate device.
Are there any special storage or handling requirements for this controller?
The data does not specify unique storage conditions; standard practice for Class 1 dental controllers is to keep the unit in a clean, dry environment and protect the cord and handpiece from physical damage.
Who manufactures the ELEC ENGINE ISE-170L and where is it based?
Micro‑Nx Co., Ltd. manufactures the device. The company’s address is 22, Maeyeo‑Ro 1‑Gil, Dong‑Gu, Daegu, South Korea.
This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: Micronx ELEC ENGINE ISE-170L Manuals | ManualsLib, K231562 FDA 510 (k) - ELEC ENGINE (Model: ISE-170L), ELEC ENGINE (Model: ISE-170L) 510(k) K231562 - FDA.report, PDF Priscilla Chu
Authorization Coverage (2 countries)
Regulatory Authorizations
MDD
FDA_510K
| Source | Region | Type | Cert / Approval No. | Class | Status |
|---|---|---|---|---|---|
| EUDAMED | European Union | MDD | — | Class I | Active |
| FDA 510(k) | United States | FDA_510K | K231562 | Class I | Active |
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Manufacturer
- Manufacturer
- MICRO-NX Co., Ltd.
Sources (2)
- FDA 510(k) K231562 24 fields · synced Sep 27, 2026
- EUDAMED 1 fields · synced May 19, 2026