Brasseler USA
F1S/2S6 Sugarman 1/2S W/6 HDL 1P
5manufacturers in China registered for this device type
21catalogue 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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EMR |
| Device type | File, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2024-04-19 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023482U0 | In distribution | |
| 5023315U0 | In distribution | |
| 5025469U0 | In distribution | |
| 5025468U0 | In distribution | |
| 5025498U0 | In distribution | |
| 5025454U0 | In distribution | |
| 5023490U0 | In distribution | |
| 5025829U0 | In distribution | |
| 5023630U0 | In distribution | |
| 5023488U0 | In distribution | |
| 5023317U0 | In distribution | |
| 5025455U0 | In distribution | |
| 5023204U0 | In distribution | |
| 5023485U0 | In distribution | |
| 5025463U0 | In distribution | |
| 5023313U0 | In distribution | |
| 5024290U0 | In distribution | |
| 5023314U0 | In distribution | |
| 5023486U0 | In distribution | |
| 5023481U0 | In distribution | |
| 5025499U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 66 |
| Kohdent | Kohler Medizintechnik GmbH | 48 |
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 26 |
| 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.