Osung MND
A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made…
A hand-held manual dental instrument designed for cutting, scraping, and removing the carious dentine of a decayed tooth or other pathological bone tissue within the oral cavity. It is made of high-grade stainless steel typically designed as a double-ended instrument, having a central handle, with small, sharp, spoon-, scoop-, or spatula-shaped blades that have sharp cutting/gouging edges. This is a reusable device.
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Hubei (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 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EKC |
| Device type | Excavator, Dental, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-04 |
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 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 3EXC31L | In distribution | |
| EXC63-64 | In distribution | |
| 3EXCL65-66 | In distribution | |
| EXCE2 | In distribution | |
| 3EXC33L | In distribution | |
| EXC18 | In distribution | |
| 3EXCL61-62 | In distribution | |
| EXC31L | In distribution | |
| EXC65-66 | In distribution | |
| 3EXCL63-64 | In distribution | |
| EXC17 | In distribution | |
| EXC33L | In distribution | |
| EXC38-39 | In distribution | |
| EXCL61-62 | In distribution | |
| 3EXC18 | In distribution | |
| 3EXC63-64 | In distribution | |
| EXCL63-64 | In distribution | |
| 3EXC32L | In distribution | |
| 3EXC38-39 | In distribution | |
| EXCE1 | In distribution | |
| EXC32L | In distribution | |
| 3EXC17 | In distribution | |
| 3EXC65-66 | In distribution | |
| EXCL65-66 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 193 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 149 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 59 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 44 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 43 |
| Excavator Double Ended | Maillefer Instruments Holding Sàrl | 36 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| Power Dental USA | Power Dental U.S.A. Inc. | 34 |
| Premier Excavators | Premier Dental Products Co. | 30 |
| Zoll-Dental | Zoll-Dental | 28 |
| Kohdent | Kohler Medizintechnik GmbH | 27 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 27 |
Showing 12 of 52. All products under Excavator, Dental, Operative
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.