N2
N2 is a dental operative unit intended to supply power to and serve as a base for dental devices and accessories. Its filing includes a dental chair and describes use in a dental clinic by…
N2 is a dental operative unit intended to supply power to and serve as a base for dental devices and accessories. Its filing includes a dental chair and describes use in a dental clinic by dental professionals, dentists or assistants.
The subject unit is offered in cart, mount and continental types. The described types include a chair, dentist and assistant elements, a dental light, a seat, stool, foot control and console.
Configuration and Operation
The filing describes hydraulic chair movement and foot-control operation of a dental handpiece by opening an air-supply valve. The handpiece and scaler are not included with the N2 subject device and are installed by end users.
Who Else Makes It
Concentrated in Guangdong (8), Shanghai (2), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Guangzhou Ajax Medical Equipment Co Ltd | Guangzhou | Guangdong | Manufacturer | 13 |
| Jiangsu Dynamic Medical Technology Co., Ltd. | Suzhou | Jiangsu | Manufacturer | 12 |
| FDC Technology Industry Company | Taishan,Guang Chong | Guangdong | Manufacturer | 6 |
| Foshan Gladent Medical Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 6 |
| Sinol Dental Limited | Xianyang | Shaanxi | Manufacturer | 5 |
| Shanghai Dental Instrument Factory Co., Ltd. | Shanghai | Shanghai | Manufacturer | 3 |
| Guangdong Yadeng Medical Apparatus Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
| Mipont Medical Equipment Co., Ltd. | Guangzhou | Guangdong | Manufacturer | 2 |
| Foshan Safety Medical Equipment Co., Ltd. | China | Guangdong | Manufacturer | 1 |
| Shanghai Fimet Medical Instrument Co., Ltd. | Shang Hai | Shanghai | Manufacturer | 1 |
Showing 12 of 13. All 13 manufacturers in China registered for Unit, Operative Dental
Record
| Listed by | Megagen Implant Co., Ltd., South Korea |
|---|---|
| FDA product code | EIA |
| Device type | Unit, Operative Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Repacker / relabeller, Manufacturer, Exporter |
| 510(k) | K240754 |
| Record published | 2024-04-02 |
| Record revised | 2026-04-17 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date, serial number |
| Distribution end date | 2024-03-21 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| N2 (Continental Type) | In distribution | |
| N2 (Mount B Type) | In distribution | |
| N2 (Cart B Type) | In distribution | |
| N2 (Cart A Type) | Withdrawn | |
| N2 (Mount A Type) | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Stradis | Stradis Healthcare | 305 |
| Forest | Ls Enterprises, Inc. | 285 |
| DCI | DCI International, LLC | 201 |
| DCI Edge | DCI International, LLC | 149 |
| A-dec | A-dec, Inc. | 66 |
| Aseptico | Aseptico, Inc. | 29 |
| Midmark | Midmark Corporation | 27 |
| Unit, Operative Dental | Ergonomic Products, Inc. | 20 |
| TPS | Stryker GmbH | 20 |
| Evogue Dental Unit | Takara Belmont Corporation | 20 |
| Belmont X-Calibur Unit | Takara Belmont Corporation | 19 |
| Dentacenter Operative Dental Unit | Safari Dentaire Inc | 12 |
Showing 12 of 224. All products under Unit, Operative Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K240754 | 2024-03-21 |
| K211556 | 2023-04-05 |
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.