RC-Prep
RC-Prep Syringe Kit - Five 3 cc syringes + 50 tips
8manufacturers in China registered for this device type
7catalogue numbers in this listing
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 | Premier Dental Products Co., United States |
|---|---|
| FDA product code | EKQ |
| Device type | Preparer, Root Canal Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2023-06-13 |
| Record revised | 2024-08-08 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| Packaging | Pack of 10 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 9007132 | In distribution | |
| 9007135 | In distribution | |
| 9007129 | In distribution | |
| 900-7135 | In distribution | |
| 9007133 | In distribution | |
| 9007125 | In distribution | |
| 9007131 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dental City | ICP, Inc. | 135 |
| Top Quality Manufacturing | TOP Quality Manufacturing, Inc. | 111 |
| 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 |
| Gates-Glidden Drills RA, N°4 | 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.