Hu-Friedy MFG Co., LLC.
#1S/2S Sugarman DE File,Smooth Satin Hdl
5manufacturers in China registered for this device type
26catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangdong (1), Zhejiang (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Sino Ortho Limited | Hangzhou | Zhejiang | Contract manufacturer | 14 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guangzhou OO Medical Scientific Limited | Guangzhou | Guangdong | Manufacturer | 17 |
| Funing Meitedental Factory | Yancheng | Jiangsu | Manufacturer | 11 |
Record
| Listed by | HU-Friedy MFG Co., LLC, United States |
|---|---|
| FDA product code | EMR |
| Device type | File, Periodontic |
| 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 | 2023-06-27 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| FS3/4S6 | In distribution | |
| FH5/11CH | In distribution | |
| FS1/2SCH | In distribution | |
| FO10/116 | In distribution | |
| FH7158 | In distribution | |
| FH6722KA | In distribution | |
| FB11/12 | In distribution | |
| FH3/7CH | In distribution | |
| FH5/11 | In distribution | |
| FH3/76 | In distribution | |
| FO12/136 | In distribution | |
| FH3/7 | In distribution | |
| FO10/11 | In distribution | |
| FO12/13 | In distribution | |
| FS9/10S | In distribution | |
| FS9/10SCH | In distribution | |
| FH5/116 | In distribution | |
| SDCN7 | In distribution | |
| FH9/106 | In distribution | |
| FS1/2S | In distribution | |
| FB11/126 | In distribution | |
| FH9/10 | In distribution | |
| SDCM/D7 | In distribution | |
| FS3/4S | In distribution | |
| FS9/10S6 | In distribution | |
| FS1/2S6 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 66 |
| Kohdent | Kohler Medizintechnik GmbH | 48 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 21 |
| Quinelato | Schobell Industrial Ltda | 16 |
| Power Dental USA | Power Dental U.S.A. Inc. | 10 |
| Zoll-Dental | Zoll-Dental | 10 |
| Sterling | Benco Dental Supply Co. | 9 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 8 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 8 |
| devemed | Devemed Gmbh | 6 |
| Reicodent | Devemed Gmbh | 6 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 4 |
Showing 12 of 39. All products under File, Periodontic
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.