Biotem
Biotem CORTICAL DRILL 5.0mm(D)X11.5mm(L)
20manufacturers in China registered for this device type
59catalogue 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 | Biotem Co., Ltd., South Korea |
|---|---|
| FDA product code | DZA |
| Device type | Drill, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4130 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-06-02 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Latex | Labelled latex-free |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| CDA4013S | In distribution | |
| BTTD37085 | In distribution | |
| BTTD37100 | In distribution | |
| STD20 | In distribution | |
| CDA5011T | In distribution | |
| STD20130 | In distribution | |
| TD46 | In distribution | |
| STD20075 | In distribution | |
| BTTD34075 | In distribution | |
| CDA4511T | In distribution | |
| TD60 | In distribution | |
| BTTD37130 | In distribution | |
| BTTD46085 | In distribution | |
| TD42 | In distribution | |
| CDA6013S | In distribution | |
| STD20100 | In distribution | |
| GD18 | In distribution | |
| BTTD46130 | In distribution | |
| DS075 | In distribution | |
| BTTD46115 | In distribution | |
| TD51 | In distribution | |
| CDA4011T | In distribution | |
| BTTD34115 | In distribution | |
| TD2329 | In distribution | |
| BTTD42115 | In distribution | |
| STD20115 | In distribution | |
| BTTD60075 | In distribution | |
| BTTD60115 | In distribution | |
| BTTD60100 | In distribution | |
| BTTD46100 | In distribution | |
| DS100 | In distribution | |
| BTTD51115 | In distribution | |
| BTTD34100 | In distribution | |
| BTTD37115 | In distribution | |
| BTTD42075 | In distribution | |
| DS130 | In distribution | |
| BHM | In distribution | |
| BTTD42100 | In distribution | |
| CDA5013S | In distribution | |
| BTTD34130 | In distribution | |
| BTTD51130 | In distribution | |
| STD20085 | In distribution | |
| DE | In distribution | |
| BTTD46075 | In distribution | |
| TD34 | In distribution | |
| BTTD51085 | In distribution | |
| BTTD34085 | In distribution | |
| BTTD60085 | In distribution | |
| CDA6011T | In distribution | |
| BTTD37075 | In distribution | |
| BTTD51075 | In distribution | |
| CDA4513S | In distribution | |
| BTTD51100 | In distribution | |
| TD37 | In distribution | |
| BTTD42130 | In distribution | |
| BTTD42085 | In distribution | |
| DS085 | In distribution | |
| BHS | In distribution | |
| DS115 | 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.