Dentacenter Operative Dental Unit
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other…
Fully-contained mobile dental unit and accessories. The AC-powered device Is intended to supply power and to serve as a base for other dental devices such as a dental handpiece, and other dental devices and accessories.
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 | Safari Dentaire Inc |
|---|---|
| FDA product code | EIA |
| Device type | Unit, Operative Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| 510(k) | K100212 |
| Record published | 2023-10-05 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | manufacturing date, serial number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| SAF-430-2 | In distribution | |
| SAF-500-CART | In distribution | |
| SAF-606-2.6 | In distribution | |
| SAF-430 | In distribution | |
| SAF-470 | In distribution | |
| SAF-430-2XP | In distribution | |
| SAF-500-M2 | In distribution | |
| SAF-531-Series II | In distribution | |
| SAF-500-M4 | In distribution | |
| SAF-430-2 | In distribution | |
| SAF-430-2XP | In distribution | |
| SAF-606-4.6 | In distribution |
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 |
| Unit, Operative Dental | Stryker GmbH | 11 |
Showing 12 of 224. All products under Unit, Operative Dental
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.