Stoma®
Crown remover w. weight, spring and3 inserts, 25cm
5manufacturers in China registered for this device type
13catalogue 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 | Storz AM Mark Gmbh, Germany |
|---|---|
| FDA product code | EIS |
| Device type | Remover, Crown |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2020-08-27 |
| 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 |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5315.02 | In distribution | |
| 5312.00 | In distribution | |
| 5325.00 | In distribution | |
| 5315.01 | In distribution | |
| 5315.10 | In distribution | |
| 5318.05 | In distribution | |
| 5305.00 | In distribution | |
| 5318.08 | In distribution | |
| 5302.00 | In distribution | |
| 5318.06 | In distribution | |
| 5304.00 | In distribution | |
| 5316.00 | In distribution | |
| 5315.03 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| 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 |
| 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.