HU-Friedy
#2X Miller-Colburn Bone File
6manufacturers in China registered for this device type
24catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Beijing (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
| Univy Technology Advanced Co., Ltd. | Shanghai | Shanghai | Manufacturer | 8 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EMI |
| Device type | File, Bone, Surgical |
| 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 | 2020-08-14 |
| Record revised | 2024-10-22 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number |
| Distribution end date | 2024-05-08 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| BF1W6 | In distribution | |
| BF2W | In distribution | |
| BF2X | In distribution | |
| BF45 | In distribution | |
| BF646 | In distribution | |
| BF3X6 | In distribution | |
| BF21 | In distribution | |
| BF1X | In distribution | |
| BF1W | In distribution | |
| BF126 | In distribution | |
| BF526 | In distribution | |
| BF64 | In distribution | |
| BF67 | In distribution | |
| BF676 | In distribution | |
| BF3X | In distribution | |
| BF1X6 | In distribution | |
| BF12 | In distribution | |
| BF456 | In distribution | |
| BF2W6 | In distribution | |
| BF52 | In distribution | |
| BF2X6 | In distribution | |
| BF1865 | In distribution | |
| BF216 | In distribution | |
| 10-465 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| DentaSonic | GC Orthodontics America Inc. | 37 |
| Reicodent | Devemed Gmbh | 22 |
| Zoll-Dental | Zoll-Dental | 21 |
| File | KLS-Martin L.P. | 20 |
| devemed | Devemed Gmbh | 18 |
| Sklar® | Sklar Corporation | 16 |
| Ambler Surgical | Ambler Surgical, LLC | 10 |
| File, Bone, Surgical | Biomet Microfixation | 10 |
| Quinelato | Schobell Industrial Ltda | 9 |
| V. Mueller | Steris Corporation | 9 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 7 |
| gSource | Gsource, LLC. | 7 |
Showing 12 of 66. All products under File, Bone, Surgical
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.