Smartlite Pro Endo Activator Activator
3 catalogue numbers from 644437, listed by Dentsply LLC, United States, under Preparer, Root Canal Endodontic. 8 manufacturers in China are registered for this product code.
8manufacturers in China registered for this device type
3catalogue 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 | Dentsply LLC, United States |
|---|---|
| FDA product code | EKQ |
| Device type | Preparer, Root Canal Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 644437 | In distribution | |
| 644436 | In distribution | |
| 644435 | 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 |
| 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.