Helmut Zepf
Osteotome Instrument, Concave, Angulated Concave, Angled, Ø 3,4 / 3,8 RED Mark, FOR Implants With Ø 4.3
4manufacturers in China registered for this device type
101catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (1), Shandong (1), Jiangsu (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| B.Braun Medical (Suzhou) Co,.Ltd | Suzhou | Jiangsu | Contract manufacturer | 37 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EMM |
| Device type | Chisel, Osteotome, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-12-12 |
| Record revised | 2023-12-07 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 47.949.11 | In distribution | |
| 47.949.95 | In distribution | |
| 47.962.50 | In distribution | |
| 47.099.50 | In distribution | |
| 41.552.06 | In distribution | |
| 47.990.50 | In distribution | |
| 47.991.00 | In distribution | |
| 47.961.20 | In distribution | |
| 47.962.33 | In distribution | |
| 47.949.23 | In distribution | |
| 47.943.43 | In distribution | |
| 24.751.512 | In distribution | |
| 47.942.33 | In distribution | |
| 24.493.01 | In distribution | |
| 47.942.20 | In distribution | |
| 41.552.10 | In distribution | |
| 47.961.33 | In distribution | |
| 47.949.03 | In distribution | |
| 47.961.38 | In distribution | |
| 41.853.11 | In distribution | |
| 24.490.01 | In distribution | |
| 24.744.70HZU | In distribution | |
| 41.550.06 | In distribution | |
| 47.945.28 | In distribution | |
| 24.748.35OX | In distribution | |
| 47.943.38 | In distribution | |
| 47.962.20 | In distribution | |
| 41.550.10 | In distribution | |
| 47.945.38 | In distribution | |
| 47.750.03 | In distribution | |
| 47.990.06 | In distribution | |
| 47.944.20 | In distribution | |
| 47.942.38 | In distribution | |
| 47.962.28 | In distribution | |
| 47.949.04 | In distribution | |
| 47.943.33 | In distribution | |
| 47.961.28 | In distribution | |
| 47.990.40 | In distribution | |
| 47.945.33 | In distribution | |
| 47.991.70 | In distribution | |
| 41.550.08 | In distribution | |
| 47.990.08 | In distribution | |
| 47.949.90 | In distribution | |
| 47.099.33 | In distribution | |
| 41.550.00 | In distribution | |
| 47.944.38 | In distribution | |
| 24.491.01 | In distribution | |
| 47.949.12 | In distribution | |
| 24.493.02 | In distribution | |
| 47.942.28 | In distribution | |
| 47.945.43 | In distribution | |
| 47.748.31HZU | In distribution | |
| 47.748.41HZU | In distribution | |
| 47.962.43 | In distribution | |
| 24.751.512OX | In distribution | |
| 47.099.34 | In distribution | |
| 47.099.32 | In distribution | |
| 47.949.01 | In distribution | |
| 47.961.00 | In distribution | |
| 47.949.13 | In distribution | |
| 47.099.31 | In distribution | |
| 41.854.10 | In distribution | |
| 47.990.20 | In distribution | |
| 47.991.60 | In distribution | |
| 47.962.38 | In distribution | |
| 47.949.02 | In distribution | |
| 47.963.60 | In distribution | |
| 47.949.07 | In distribution | |
| 47.990.30 | In distribution | |
| 47.943.28 | In distribution | |
| 47.944.43 | In distribution | |
| 47.942.43 | In distribution | |
| 47.945.20 | In distribution | |
| 24.744.85HZU | In distribution | |
| 47.750.04 | In distribution | |
| 41.854.20 | In distribution | |
| 47.750.14 | In distribution | |
| 47.750.13 | In distribution | |
| 47.991.10 | In distribution | |
| 47.991.50 | In distribution | |
| 41.552.08 | In distribution | |
| 24.744.80HZU | In distribution | |
| 47.991.30 | In distribution | |
| 47.944.28 | In distribution | |
| 24.491.02 | In distribution | |
| 47.991.20 | In distribution | |
| 47.990.10 | In distribution | |
| 47.961.43 | In distribution | |
| 47.949.22 | In distribution | |
| 47.991.80 | In distribution | |
| 47.949.06 | In distribution | |
| 47.963.50 | In distribution | |
| 24.494.00 | In distribution | |
| 47.990.60 | In distribution | |
| 47.943.20 | In distribution | |
| 47.990.00 | In distribution | |
| 47.991.40 | In distribution | |
| 47.949.21 | In distribution | |
| 47.990.70 | In distribution | |
| 47.944.33 | In distribution | |
| 47.949.05 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sklar® | Sklar Corporation | 482 |
| gSource | Gsource, LLC. | 296 |
| Tatum Surgical-Osteotome | Suncoast Dental, Inc. | 108 |
| Kohdent | Kohler Medizintechnik GmbH | 86 |
| MSI Precision Specialty Instruments | MED Saver, Inc. | 78 |
| ACE | Ace Surgical Supply Co., Inc. | 73 |
| Osteotome | KLS-Martin L.P. | 70 |
| Aesculap | Aesculap AG | 69 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 64 |
| Millennium | Avalign Technologies, Inc. | 63 |
| devemed | Devemed Gmbh | 63 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 54 |
Showing 12 of 283. All products under Chisel, Osteotome, 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.