Osung MND
A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but…
A hand-held, manual, dental surgical instrument intended to be used as a lever during the extraction of a tooth or retained roots. It is typically a one-piece instrument with a strong but slender blade at the distal working end, or it may be double-ended with a central handle. It is available in a variety of sizes and blade designs and is pushed in between the gums and the tooth exterior to loosen the tissue surrounding the tooth. Sometimes this can be enough to loosen and extract the tooth without the use of other instruments. This is a reusable device.
6manufacturers in China registered for this device type
126catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), 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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Changsha Nice Medical Instrument Limited Company | Changsha | Hunan | Manufacturer | 17 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EMJ |
| Device type | Elevator, Surgical, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-26 |
| Record revised | 2025-11-03 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Label carries | lot or batch number, expiry date, manufacturing date, serial number |
| Distribution end date | 2025-10-31 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| EL34 | In distribution | |
| MXP9SC | In distribution | |
| 3EL34S | In distribution | |
| 3EL31F | In distribution | |
| 3EL301A | In distribution | |
| 3ELLR302 | In distribution | |
| EP16 | In distribution | |
| 4ELLR501 | In distribution | |
| 4ELLD501 | In distribution | |
| ERP3 | In distribution | |
| EL34S | In distribution | |
| EPBUSER | In distribution | |
| MXP6C | In distribution | |
| EP14 | In distribution | |
| ISSL4 | In distribution | |
| EL41 | In distribution | |
| MXP6S | In distribution | |
| 4ELL301 | In distribution | |
| MXP3S | In distribution | |
| 3ELLR502 | In distribution | |
| ERP2 | In distribution | |
| EL81 | In distribution | |
| 4ELLR30K | In distribution | |
| ISSL3 | In distribution | |
| 3ELLD502 | In distribution | |
| 3EL41 | In distribution | |
| 3ELLR501 | In distribution | |
| EL31F | In distribution | |
| 4ELLR301 | In distribution | |
| MXP75S | In distribution | |
| EPKN1 | In distribution | |
| 4EL304W | In distribution | |
| EL4 | In distribution | |
| 3EL52 | In distribution | |
| 3ELLR303 | In distribution | |
| ISSL1 | In distribution | |
| 4EL81 | In distribution | |
| MXP3SC | In distribution | |
| 4EL41 | In distribution | |
| 4EL4 | In distribution | |
| MXP9C | In distribution | |
| 3EL74 | In distribution | |
| 3EL32F | In distribution | |
| 4ERP3 | In distribution | |
| 3ELL502 | In distribution | |
| 3ELLD50K | In distribution | |
| 3ELL30K | In distribution | |
| EP9S | In distribution | |
| 3ELL50K | In distribution | |
| EL52 | In distribution | |
| ISSLKIT | In distribution | |
| MXP6SC | In distribution | |
| MXP9S | In distribution | |
| 3EL304W | In distribution | |
| 4ELL502 | In distribution | |
| 3ELLR50K | In distribution | |
| 3ELLR301 | In distribution | |
| EP15 | In distribution | |
| EL32F | In distribution | |
| 4ELLR302 | In distribution | |
| 3EL5 | In distribution | |
| 4EL5 | In distribution | |
| 3EL81 | In distribution | |
| EL73 | In distribution | |
| 4ELLR303 | In distribution | |
| 4ELLR502 | In distribution | |
| 4ELLR503 | In distribution | |
| ERHB13-14 | In distribution | |
| 3ELL303 | In distribution | |
| EP9H | In distribution | |
| EP20 | In distribution | |
| 4ELL302 | In distribution | |
| 4EL34 | In distribution | |
| 3ELLD501 | In distribution | |
| EP23 | In distribution | |
| 4ELL50K | In distribution | |
| 4ELLD50K | In distribution | |
| 3ELL503 | In distribution | |
| 3EL73 | In distribution | |
| EL304W | In distribution | |
| 3ERP3 | In distribution | |
| 3ELL302 | In distribution | |
| IS6577SC5 | In distribution | |
| 4EL32F | In distribution | |
| 3ERP1 | In distribution | |
| MXP3C | In distribution | |
| 3ELLD503 | In distribution | |
| ISSL2 | In distribution | |
| 4EL301A | In distribution | |
| 4EL34S | In distribution | |
| 4EL31F | In distribution | |
| EPPR3 | In distribution | |
| IS65785 | In distribution | |
| 3ELL301 | In distribution | |
| 3ERP2 | In distribution | |
| 4EL52 | In distribution | |
| EP9 | In distribution | |
| 4EL301 | In distribution | |
| EL74 | In distribution | |
| 4EL73 | In distribution | |
| EL5 | In distribution | |
| 4ELLD503 | In distribution | |
| ERP1 | In distribution | |
| ISSC1 | In distribution | |
| 4ELLD502 | In distribution | |
| ISSC2 | In distribution | |
| 3EL4 | In distribution | |
| 3ELLR30K | In distribution | |
| 4EL74 | In distribution | |
| 4ELL303 | In distribution | |
| 4ELL501 | In distribution | |
| 3ELLR503 | In distribution | |
| 3ELL501 | In distribution | |
| MXS1 | In distribution | |
| 4ELLR50K | In distribution | |
| 4ELL30K | In distribution | |
| EL301A | In distribution | |
| 4ERP1 | In distribution | |
| 3EL301 | In distribution | |
| 3EL34 | In distribution | |
| ISPKN152 | In distribution | |
| EL301 | In distribution | |
| 4ERP2 | In distribution | |
| EP24G | In distribution | |
| 4ELL503 | In distribution | |
| 4ERP2 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 465 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 264 |
| Power Dental USA | Power Dental U.S.A. Inc. | 247 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 233 |
| Elevator | KLS-Martin L.P. | 231 |
| Kohdent | Kohler Medizintechnik GmbH | 206 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 153 |
| Stoma® | Storz AM Mark Gmbh | 150 |
| Reicodent | Devemed Gmbh | 142 |
| Sklar | Sklar Corporation | 130 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 121 |
| Elevator, Surgical, Dental | Biomet Microfixation | 120 |
Showing 12 of 743. All products under Elevator, 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.