Zoral
Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM #…
Zoral® System is a Portable Self-Contained Bottle System that dispenses a liquid irrigating ultrasonic solution to a dental scaler during dental hygiene cleaning procedures (ITEM # MAK-1310). Zoral System is attached to the dental unit’s quick disconnect air to pressurize the Zoral System.
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 | Anodia Systems, United States |
|---|---|
| FDA product code | EIA |
| Device type | Unit, Operative Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6640 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| 510(k) | K023213 |
| Record published | 2023-08-19 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 00854542008372 | 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 |
| Dentacenter Operative Dental Unit | Safari Dentaire Inc | 12 |
Showing 12 of 224. All products under Unit, Operative Dental
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K023815 | 2003-06-19 |
| K023896 | 2003-06-19 |
| K023213 | 2003-01-16 |
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.