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…
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.
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.
| 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
| 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
| 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 number | Size | Status |
|---|---|---|
| EnDriveUS | In distribution |
Same 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.