Prima
Bone Profiler
20manufacturers in China registered for this device type
76catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (6), Jiangsu (5), Anhui (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Digital Dental Depot | Zhuhai | Guangdong | Contract manufacturer | 17 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| TF NEW Material SCI AND TEC Co., Ltd. | Huainan | Anhui | Manufacturer | 51 |
| Hefei Mlush Sanitary Products Co., Ltd. | Hefei | Anhui | Manufacturer | 48 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
| Chengdu Besmile Medical Technology Co., Ltd. | Chengdu | Sichuan | Manufacturer | 14 |
Showing 12 of 20. All 20 manufacturers in China registered for Drill, Dental, Intraoral
Record
| Listed by | Keystone Dental Inc., United States |
|---|---|
| FDA product code | DZA |
| Device type | Drill, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4130 |
| Establishment | Complaint-file establishment, Manufacturer, Exporter |
| 510(k) | K051614 |
| Record published | 2019-05-08 |
| Record revised | 2025-12-01 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 15202K | In distribution | |
| 15216K | In distribution | |
| 15675K | In distribution | |
| 15672K | In distribution | |
| 15207K | In distribution | |
| 15660K | In distribution | |
| 15251K | In distribution | |
| 15662K | In distribution | |
| 15205K | In distribution | |
| 15210K | In distribution | |
| 15676K | In distribution | |
| 15657K | In distribution | |
| 15256K | In distribution | |
| 15663K | In distribution | |
| 15262K | In distribution | |
| 15250K | In distribution | |
| 15255K | In distribution | |
| E20101 | In distribution | |
| 15101K | In distribution | |
| 15260K | In distribution | |
| 15280K | In distribution | |
| 15248K | In distribution | |
| 15678K | In distribution | |
| 15671K | In distribution | |
| 15670K | In distribution | |
| 15653K | In distribution | |
| 15656K | In distribution | |
| 15237K | In distribution | |
| 15654K | In distribution | |
| 15667K | In distribution | |
| 15204K | In distribution | |
| 15281K | In distribution | |
| 15261K | In distribution | |
| 15208K | In distribution | |
| 15252K | In distribution | |
| 15217K | In distribution | |
| 15075K | In distribution | |
| 15674K | In distribution | |
| 15661K | In distribution | |
| 15664K | In distribution | |
| 15263K | In distribution | |
| 15203K | In distribution | |
| 15655K | In distribution | |
| 15076K | In distribution | |
| 15264K | In distribution | |
| 15254K | In distribution | |
| 15214K | In distribution | |
| 15673K | In distribution | |
| 15253K | In distribution | |
| 15236K | In distribution | |
| 15258K | In distribution | |
| 15211K | In distribution | |
| 15215K | In distribution | |
| 15658K | In distribution | |
| 15778K | In distribution | |
| 15212K | In distribution | |
| 15247K | In distribution | |
| 15219K | In distribution | |
| 15652K | In distribution | |
| 15213K | In distribution | |
| 15265K | In distribution | |
| 15218K | In distribution | |
| 15679K | In distribution | |
| 15659K | In distribution | |
| 15257K | In distribution | |
| 15669K | In distribution | |
| 15279K | In distribution | |
| 15238K | In distribution | |
| 15239K | In distribution | |
| 15665K | In distribution | |
| 15209K | In distribution | |
| 15206K | In distribution | |
| 15259K | In distribution | |
| 15201K | In distribution | |
| 15200K | In distribution | |
| 15668K | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Neobiotech Implant System | Neobiotech Co., Ltd. | 685 |
| Jota | Jota AG | 307 |
| OneGuide Taper Drill | Osstem Implant Co., Ltd. | 291 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 286 |
| 122 Taper Drill | Osstem Implant Co., Ltd. | 285 |
| Taper Drill | Osstem Implant Co., Ltd. | 279 |
| Edenta | Edenta Etablissement | 275 |
| Bone Compaction Drill | Osstem Implant Co., Ltd. | 200 |
| Dental Surgical Drill | Cowellmedi Co., Ltd. | 195 |
| Twist Drill | Osstem Implant Co., Ltd. | 169 |
| Bondent | United Dental Changzhou | 166 |
| Ritter Implants Dental System | Ritter Implants GmbH & Co. KG | 156 |
Showing 12 of 875. All products under Drill, Dental, Intraoral
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.