PRO M Class
Pro M Class is a powered dental handpiece system for dental professionals. It is used with root canal instruments in orthodontic and endodontic procedures and to tighten or loosen implant…
Pro M Class is a powered dental handpiece system for dental professionals. It is used with root canal instruments in orthodontic and endodontic procedures and to tighten or loosen implant abutment screws during prosthodontic treatment.
A battery inside the motor handpiece powers a micromotor that transmits rotation to the contra-angle handpiece. The controls allow the user to start and stop rotation and adjust speed, torque and turning direction.
Listed Item
The PRO M CLASS is an AC-powered device that includes a “Motor Handpiece”,”Contra angle Handpiece”,”Charger unit” and “AC/DC Adaptor” for grinding, cutting, polishing and screw driver work in dental oral use.
Working Instruments
Dental burs are supplied separately from the system.
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 | Saeyang Microtech Co., Ltd., South Korea |
|---|---|
| FDA product code | EKX |
| Device type | Handpiece, Direct Drive, Ac-Powered |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4200 |
| 510(k) | K213897 |
| Record published | 2023-06-07 |
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 number | Size | Status |
|---|---|---|
| PRO M CLASS | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K213897 | 2022-09-19 |
| K123582 | 2013-08-16 |
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.