Helmut Zepf
Remover, Crown-Remover, Double-Ended Straight / Curved Combination; FOR Anterior & Posterior, Bionik Handle;
5manufacturers in China registered for this device type
35catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Guangxi (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Helmut Zepf Medizintechnik Gmbh, Germany |
|---|---|
| FDA product code | EIS |
| Device type | Remover, Crown |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer, Exporter |
| Premarket notification | Exempt |
| Record published | 2022-11-30 |
| Record revised | 2025-04-18 (version 3) |
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 |
|---|---|---|
| 19.277.01Z | In distribution | |
| 19.265.02 | In distribution | |
| 19.270.50 | In distribution | |
| 19.265.00 | In distribution | |
| 19.265.10 | In distribution | |
| 19.277.01 | In distribution | |
| 19.281.16 | In distribution | |
| 19.265.08 | In distribution | |
| 19.279.00 | In distribution | |
| 19.272.02 | In distribution | |
| 19.275.02 | In distribution | |
| 19.265.01 | In distribution | |
| 19.265.04 | In distribution | |
| 19.275.04 | In distribution | |
| 19.273.00 | In distribution | |
| 19.265.09 | In distribution | |
| 19.265.05 | In distribution | |
| 19.265.16 | In distribution | |
| 19.274.16 | In distribution | |
| 19.272.03 | In distribution | |
| 19.274.13 | In distribution | |
| 19.275.01 | In distribution | |
| 19.272.01 | In distribution | |
| 19.274.15 | In distribution | |
| 19.281.15TC | In distribution | |
| 19.274.01 | In distribution | |
| 19.272.10 | In distribution | |
| 19.272.00 | In distribution | |
| 19.265.06 | In distribution | |
| 19.265.07 | In distribution | |
| 19.274.00 | In distribution | |
| 19.274.12 | In distribution | |
| 19.275.00 | In distribution | |
| 19.265.03 | In distribution | |
| 19.274.10 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| devemed | Devemed Gmbh | 35 |
| Zoll-Dental | Zoll-Dental | 25 |
| Reicodent | Devemed Gmbh | 25 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 20 |
| Paul Banditt | Terlain Enterprises, Inc. | 16 |
| Stoma® | Storz AM Mark Gmbh | 13 |
| Osung MND | Osung MND Co., Ltd. | 12 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 11 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 11 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 9 |
| Kohdent | Kohler Medizintechnik GmbH | 9 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
Showing 12 of 59. All products under Remover, Crown
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.