Elec Engine (Model: ISE-170L)

ELEC ENGINE ISE-170L supplies power and control to a dental micromotor and handpiece for oral surgery and implant procedures. The connected handpiece carries the tool used to cut hard…

Registry build 21.09.26

ELEC ENGINE ISE-170L supplies power and control to a dental micromotor and handpiece for oral surgery and implant procedures. The connected handpiece carries the tool used to cut hard tissue in the mouth.

The system combines a control unit, brushless DC motor and wired foot control. External AC power is converted to DC power, and the motor produces the rotary drive for the connected handpiece. An irrigation tube is included with the system.

Motor and Programs

The motor operates across a stated speed range of 200 to 40,000 revolutions per minute. The control memory contains six preset implant systems and nine user-defined programs with nine steps each. These are motor and controller features; the selected handpiece and tool determine the working configuration.

4manufacturers in China registered for this device type
1catalogue number
3510(k) clearances naming this product code

Who Else Makes It

Concentrated in Guangxi (2), Guangdong (2).

Chinese manufacturers registered for FDA product code EBW
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Guangxi Ehall Medical Technology Co., Ltd. Nanning Guangxi Manufacturer 17
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15

Record

Regulatory record for Elec Engine (Model: ISE-170L)
Listed by Micro-NX Co., Ltd., South Korea
FDA product code EBW
Device type Controller, Foot, Handpiece And Cord
Device class Class 1
Regulation 21 CFR 872.4200
Establishment Manufacturer
510(k) K231562
Record published 2026-06-30

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Elec Engine (Model: ISE-170L)
Catalogue number Size Status
ISE-170L In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
A-dec A-dec, Inc. 43
X-Cube Saeshin Precision Co., Ltd. 22
Maxso Beyes Dental Canada, Inc. 20
NLZ Nakanishi Inc. 16
Surgic Pro Nakanishi Inc. 15
Brasseler USA Peter Brasseler Holdings, LLC 13
DTE Guilin Woodpecker Medical Instrument Co., Ltd. 11
woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 10
NL400 Nakanishi Inc. 9
NLX Nakanishi Inc. 9
Surgic XT Plus Nakanishi Inc. 6
Axiom® Etablissements Anthogyr 6

Showing 12 of 256. All products under Controller, Foot, Handpiece And Cord

510(K) Clearances

FDA 510(k) clearances naming this product code
Clearance Decision date
K231562 2025-07-18
K201191 2022-02-07
K201192 2021-05-21

Source: U.S. FDA establishment registration and device listing records, public domain. Restructured for clarity and searchability. Not affiliated with or endorsed by the FDA. Records are records: nothing here is an offer of sale.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer