DiaPrep Pro
DiaPrep Pro is an EDTA cream with Urea Hydrogen Peroxide, used as an irrigation agent for chemomechanical preparation of the root canal
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangxi (2), Guangdong (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hantech Medical Device Co., Ltd. | Cixi | Zhejiang | Contract manufacturer | 18 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 19 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Guilin Kevin Peter Technology Co., Ltd. | Guilin | Guangxi | Manufacturer | 13 |
| Changzhou Bomedent Medical Technology Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 6 |
| Beijing C-Root Dental Medical Devices Co., Ltd. | Beijing | Beijing | Manufacturer | 6 |
| Foshan Oreck Medical Technology Co., Ltd. | Foshan | Guangdong | Manufacturer | 2 |
Record
| Listed by | Diadent Group Intl., Inc., Canada |
|---|---|
| FDA product code | EKQ |
| Device type | Preparer, Root Canal Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Repacker / relabeller, Private-label distributor, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2023-06-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Label carries | lot or batch number, expiry date |
| Storage | Storage environment temperature 2 to 27 °C; Special storage condition: Keep Dry and Keep away from Sunlight. |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 6g | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dental City | ICP, Inc. | 135 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 111 |
| RC-Prep | Premier Dental Products Co. | 7 |
| Well-Prep | Vericom Co., Ltd. | 6 |
| C-Root | Beijing C-Root Dental Medical Devices Co., Ltd. | 5 |
| J&J Instruments | J & J Instruments, LLC | 4 |
| Smartlite Pro Endo Activator Activator | Dentsply LLC | 3 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 3 |
| Henry Schein | Henry Schein, Inc. | 3 |
| Smartlite Pro Endo Activator | Dentsply LLC | 2 |
| CanalPro | Coltene/Whaledent Gmbh & Co. KG | 2 |
| Gates-Glidden Drills RA, N°2 | Produits dentaires S.A. | 1 |
Showing 12 of 44. All products under Preparer, Root Canal Endodontic
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.