Helmut Zepf
Buser Bone Curette 3MM/5MM Double Ended Huerzeler/Zuhr Design Handle, >>working Tips Matt Finish<<
4manufacturers in China registered for this device type
45catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Guangxi (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 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Hangzhou Haizhu MIM Products Co., Ltd. | Hangzhou | Zhejiang | Exporter | 28 |
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EMK |
| Device type | Curette, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-07 |
| Record revised | 2024-06-12 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 41.751.012LUOX | In distribution | |
| 41.822.03 | In distribution | |
| 24.495.03HZU | In distribution | |
| 47.520.23 | In distribution | |
| 47.520.03 | In distribution | |
| 24.747.06 | In distribution | |
| 24.495.03 | In distribution | |
| 41.751.012LU | In distribution | |
| 41.751.33L | In distribution | |
| 41.822.11 | In distribution | |
| 41.751.011LU | In distribution | |
| 41.848.40 | In distribution | |
| 47.520.01 | In distribution | |
| 24.751.295OX | In distribution | |
| 41.751.011LUOX | In distribution | |
| 47.520.02 | In distribution | |
| 41.751.43 | In distribution | |
| 47.520.10 | In distribution | |
| 47.950.03 | In distribution | |
| 24.995.00 | In distribution | |
| 24.995.01 | In distribution | |
| 41.751.22L | In distribution | |
| 41.751.04R | In distribution | |
| 47.520.25 | In distribution | |
| 47.950.02 | In distribution | |
| 47.966.00 | In distribution | |
| 41.822.05 | In distribution | |
| 47.520.24 | In distribution | |
| 24.751.296OX | In distribution | |
| 46.035.20HZU | In distribution | |
| 41.822.04 | In distribution | |
| 41.751.11R | In distribution | |
| 41.877.23 | In distribution | |
| 24.495.02 | In distribution | |
| 41.822.02 | In distribution | |
| 47.520.22 | In distribution | |
| 41.822.01 | In distribution | |
| 41.822.33 | In distribution | |
| 41.751.04L | In distribution | |
| 41.751.33R | In distribution | |
| 41.822.22 | In distribution | |
| 41.751.22R | In distribution | |
| 24.495.01 | In distribution | |
| 24.204.35OX | In distribution | |
| 41.751.11L | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Surgical Direct | Surgical Direct, Inc. | 693 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 170 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 112 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 85 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 72 |
| Paul Banditt | Terlain Enterprises, Inc. | 52 |
| Sklar® | Sklar Corporation | 40 |
| Anatomic Colours | Aesculap AG | 39 |
| Zoll-Dental | Zoll-Dental | 39 |
| Aesculap | Aesculap AG | 39 |
| devemed | Devemed Gmbh | 33 |
| Reicodent | Devemed Gmbh | 30 |
Showing 12 of 107. All products under Curette, Surgical, Dental
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.