Top Quality Manufacturing
TQMPL Smart-Flex Heat Treated Endodontic Reciprocating Rotary Files - Medium - Green - 21 mm
8manufacturers in China registered for this device type
111catalogue 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 | TOP Quality Manufacturing, Inc. |
|---|---|
| FDA product code | EKQ |
| Device type | Preparer, Root Canal Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2024-10-28 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 12609165 | 3 | In distribution | |
| 12609200 | 4 | In distribution | |
| 12609166 | 3 | In distribution | |
| 12609149 | 6 | In distribution | |
| 12609124 | 6 | In distribution | |
| 12609236 | 4 | In distribution | |
| 12609222 | 4 | In distribution | |
| 12609179 | 3 | In distribution | |
| 12609223 | 4 | In distribution | |
| 12609231 | 4 | In distribution | |
| 12609162 | 6 | In distribution | |
| 12609126 | 6 | In distribution | |
| 12609210 | 4 | In distribution | |
| 12609233 | 4 | In distribution | |
| 12609217 | 4 | In distribution | |
| 12609203 | 4 | In distribution | |
| 12609229 | 4 | In distribution | |
| 12609228 | 4 | In distribution | |
| 12609172 | 4 | In distribution | |
| 12609161 | 6 | In distribution | |
| 12609183 | 3 | In distribution | |
| 12609175 | 3 | In distribution | |
| 12609227 | 4 | In distribution | |
| 12609144 | 6 | In distribution | |
| 12609199 | 4 | In distribution | |
| 12609201 | 4 | In distribution | |
| 12609122 | 6 | In distribution | |
| 12609181 | 4 | In distribution | |
| 12609163 | 3 | In distribution | |
| 12609169 | 3 | In distribution | |
| 12609151 | 6 | In distribution | |
| 12609232 | 4 | In distribution | |
| 12609206 | 4 | In distribution | |
| 12609208 | 4 | In distribution | |
| 12609220 | 4 | In distribution | |
| 12609204 | 4 | In distribution | |
| 12609120 | 6 | In distribution | |
| 12609132 | 6 | In distribution | |
| 12609219 | 4 | In distribution | |
| 12609193 | 4 | In distribution | |
| 12609230 | 4 | In distribution | |
| 12609197 | 4 | In distribution | |
| 12609194 | 4 | In distribution | |
| 12609239 | 4 | In distribution | |
| 12609186 | 4 | In distribution | |
| 12609150 | 6 | In distribution | |
| 12609224 | 4 | In distribution | |
| 12609118 | 6 | In distribution | |
| 12609221 | 4 | In distribution | |
| 12609213 | 4 | In distribution | |
| 12609202 | 4 | In distribution | |
| 12609170 | 3 | In distribution | |
| 12609130 | 6 | In distribution | |
| 12609155 | 6 | In distribution | |
| 12609184 | 3 | In distribution | |
| 12609167 | 4 | In distribution | |
| 12609225 | 4 | In distribution | |
| 12609185 | 3 | In distribution | |
| 12609180 | 3 | In distribution | |
| 12609235 | 4 | In distribution | |
| 12609240 | 4 | In distribution | |
| 12609196 | 4 | In distribution | |
| 12609148 | 6 | In distribution | |
| 12609136 | 6 | In distribution | |
| 12609212 | 4 | In distribution | |
| 12609114 | 6 | In distribution | |
| 12609192 | 4 | In distribution | |
| 12609156 | 6 | In distribution | |
| 12609178 | 3 | In distribution | |
| 12609168 | 3 | In distribution | |
| 12609177 | 3 | In distribution | |
| 12609138 | 6 | In distribution | |
| 12609211 | 4 | In distribution | |
| 12609116 | 6 | In distribution | |
| 12609158 | 6 | In distribution | |
| 12609134 | 6 | In distribution | |
| 12609152 | 6 | In distribution | |
| 12609216 | 4 | In distribution | |
| 12609214 | 4 | In distribution | |
| 12609159 | 6 | In distribution | |
| 12609191 | 4 | In distribution | |
| 12609171 | 3 | In distribution | |
| 12609146 | 6 | In distribution | |
| 12609226 | 4 | In distribution | |
| 12609187 | 3 | In distribution | |
| 12609207 | 4 | In distribution | |
| 12609173 | 3 | In distribution | |
| 12609218 | 4 | In distribution | |
| 12609154 | 6 | In distribution | |
| 12609234 | 4 | In distribution | |
| 12609174 | 3 | In distribution | |
| 12609182 | 3 | In distribution | |
| 12609157 | 6 | In distribution | |
| 12609238 | 4 | In distribution | |
| 12609153 | 6 | In distribution | |
| 12609209 | 4 | In distribution | |
| 12609215 | 4 | In distribution | |
| 12609160 | 6 | In distribution | |
| 12609188 | 3 | In distribution | |
| 12609195 | 4 | In distribution | |
| 12609198 | 4 | In distribution | |
| 12609164 | 3 | In distribution | |
| 12609190 | 3 | In distribution | |
| 12609189 | 3 | In distribution | |
| 12609128 | 6 | In distribution | |
| 12609176 | 3 | In distribution | |
| 12609205 | 4 | In distribution | |
| 12609147 | 6 | In distribution | |
| 12609142 | 6 | In distribution | |
| 12609237 | 4 | In distribution | |
| 12609140 | 6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Dental City | ICP, Inc. | 135 |
| 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 |
| 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.