Hedstroem Rotary File
Engine Hedstrom File 045-080 25mm
20manufacturers in China registered for this device type
34catalogue numbers in this listing
1510(k) clearance
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 | Tulsa Dental Products LLC, United States |
|---|---|
| FDA product code | DZA |
| Device type | Drill, Dental, Intraoral |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4130 |
| Establishment | Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-10-26 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Supplied sterile | Yes |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 671080 | 6 | In distribution | |
| 671065 | 6 | In distribution | |
| 671085 | 6 | In distribution | |
| 671070 | 6 | In distribution | |
| 671074 | 6 | In distribution | |
| 671078 | 6 | In distribution | |
| 671088 | 6 | In distribution | |
| 671086 | 6 | In distribution | |
| 671081 | 6 | In distribution | |
| 671091 | 6 | In distribution | |
| 671064 | 6 | In distribution | |
| 671084 | 6 | In distribution | |
| 671090 | 6 | In distribution | |
| 671062 | 6 | In distribution | |
| 671075 | 6 | In distribution | |
| 671068 | 6 | In distribution | |
| 671077 | 6 | In distribution | |
| 671063 | 6 | In distribution | |
| 671082 | 6 | In distribution | |
| 671059 | 6 | In distribution | |
| 671061 | 6 | In distribution | |
| 671092 | 6 | In distribution | |
| 671067 | 6 | In distribution | |
| 671069 | 6 | In distribution | |
| 671073 | 6 | In distribution | |
| 671071 | 6 | In distribution | |
| 671066 | 6 | In distribution | |
| 671058 | 6 | In distribution | |
| 671087 | 6 | In distribution | |
| 671060 | 6 | In distribution | |
| 671072 | 6 | In distribution | |
| 671083 | 6 | In distribution | |
| 671076 | 6 | In distribution | |
| 671079 | 6 | 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
510(K) Clearances
| Clearance | Decision date |
|---|---|
| K954790 | 1996-01-16 |
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.