EnDrive

EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating…

Registry build 21.09.26

EnDrive is a battery-operated electronic medical device used for the treatment of root pulp infection, which allows root canal preparation by means of continuously or alternately rotating endodontic instruments with torque control, or retreatment of an already treated tooth, with integrated apex locator. We can identify two different functional principles: one is the motor function which serves to shape the root canal, the other is the apex locator function to determine the apex approach when the file is in the root canal. The motor function, when the file has a movement transmitted from the motor through the contra-angle, allows the proper shaping of a root canal with infected pulp through rotary or reciprocating movement, helping to remove debris and infected tissue from the canal. The motor, controlled in speed and torque, uses brushless DC technology with 3 phases and 3 Hall sensors, driven by an embedded software. The apex locator function allows to determine when, during an endodontic treatment, the tip of an endodontic instrument, in steel or nickel-titanium, inserted by the dentist inside the root canal, is at the apex of the canal. Two electrodes are applied to the patient, a lip clip on the lip and a file clamp to the endodontic instrument positioned inside the canal (see figure below → same signal can be transmitted as well through the motor to the tip during the canal shaping). When the device signals the apex has been reached, the dentist positions the instrument stopper on the dental crown and indirectly goes to measure the working length of the canal using a ruler for endodontic instruments, so the length from which he must remove the infected pulp.

10manufacturers in China registered for this device type
1catalogue number

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (2), Guangxi (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code EKX
Manufacturer City Province Registered as Device types
Jung Chen Technology Co., Ltd. Zhuhai Guangdong Contract manufacturer 2
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Changzhou Sifary Medical Technology Co., Ltd. Changzhou Jiangsu Manufacturer 14
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Shenzhen Perfect Medical Instruments Co., Ltd. Shenzhen Guangdong Manufacturer 10
Changzhou Bomedent Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 6

Record

Regulatory record for EnDrive
Listed by Advanced Technology Research A.T.R. SRL
FDA product code EKX
Device type Handpiece, Direct Drive, Ac-Powered
Device class Class 1
Regulation 21 CFR 872.4200
510(k) K243692
Record published 2025-11-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Prescription Prescription only
Label carries serial number

Catalogue Numbers

Catalogue numbers for EnDrive
Catalogue number Size Status
EnDriveUS In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MulTipeg™ Integration Diagnostics Sweden AB 151
Aseptico Aseptico, Inc. 40
Brasseler USA Peter Brasseler Holdings, LLC 26
Woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 16
DTE Guilin Woodpecker Medical Instrument Co., Ltd. 16
Delfin2 Intra-Lock International 16
Ultrapro TX Cordless Ultradent Products Inc. 13
CanalPro Coltene/Whaledent Gmbh & Co. KG 12
ChecQPEG Dentis Co., Ltd. 12
EdgeApex HP™ US Endodontics, LLC 11
Penguin RFA Integration Diagnostics Sweden AB 10
Henry Schein Henry Schein, Inc. 9

Showing 12 of 307. All products under Handpiece, Direct Drive, Ac-Powered

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