Elec-Led
FDA 510(k) K201191 · Micro-Nx Co., Ltd.
510(k) numberK201191
Submission
- Device name
- Elec-Led
- Applicant
- Micro-Nx Co., Ltd.
Daegu, KR - Received
- May 4, 2020
- Decision date
- February 7, 2022
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Other 510(k)s with product code EBW
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K251407 | Motor Handpiece and Control Unit (SDI10)EBW · Traditional | Saeshin Precision Co., Ltd. | 01/30/2026SE |
| K251701 | Star E900 Electric SystemEBW · Traditional | Dentalez, Inc., Stardental Division | 01/12/2026SE |
| K251811 | Motor and Apex Module (MaAM)EBW · Traditional | Dentsply Sirona, Inc. | 08/25/2025SE |
| K231562 | ELEC ENGINE (Model: ISE-170L)EBW · Special | Micro-Nx Co., Ltd. | 07/18/2025SE |
| K242646 | Dental Implant UnitEBW · Traditional | Guilin Aesthedent Medical Instruments Co., Ltd. | 04/11/2025SE |
| K233288 | NLZ Built-In Motor SystemEBW · Traditional | Nakanishi, Inc. | 06/24/2024SE |
| K233117 | Surgic Pro2 (Surgic Pro2 OPT), Surgic Pro2 (Surgic Pro2 NON-OPT)EBW · Traditional | Nakanishi, Inc. | 06/20/2024SE |
| K230895 | CEFLA Dental Micromotors: i-MMr, i-MMr L, i-MMr L FLUO, i-MMs, i-MMs FLUO; i-XR3, i-XR3…EBW · Traditional | Cefla S.C. | 04/01/2024SE |
| K231864 | Fiber Optic Brushless Electronic Micromotor, model: iM100EBW · Traditional | Codent Technical Industry Co., Ltd. | 03/11/2024SE |
| K211358 | Implanter incl. AccessoriesEBW · Traditional | Guilin Woodpecker Medical Instrument Co., Ltd. | 11/21/2022SE |
More from Guilin Woodpecker Medical Instrument Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K231562 | ELEC ENGINE (Model: ISE-170L)EBW · Special | 07/18/2025SE |
| K232810 | Dental Handpiece, Wireless Endodontic Handpiece, endoitEKX · Traditional | 11/09/2023SE |
| K220577 | Dental Handpiece, Model CA160, CA160L, and CA500LEGS · Traditional | 07/29/2022SE |
| 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-Led cleared by the FDA?
Elec-Led (K201191) received a 510(k) decision of Substantially Equivalent on February 7, 2022, 644 days after the submission was received.
What is the product code of K201191?
The FDA product code is EBW – Controller, Foot, Handpiece And Cord, a Class I (low risk) device regulated under 21 CFR 872.4200.