Osung MND
A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a…
A hand-held manual dental instrument that has various forms of ridged cutting surfaces at its working end(s) designed to scrape and smooth during a periodontal procedure. It is typically a one-piece instrument available in a variety of sizes and working end designs, including straight and curved ends, and often double-ended with a central handle; it is made of metal [e.g., stainless steel, titanium (Ti)]. This device is typically used to remove gross supragingival calculus, smooth the cementoenamel junction (CEJ), and remove overhanging margins of dental restorations. This is a reusable device.
Who Else Makes It
Concentrated in Shanghai (3), Shandong (1), Guangxi (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 |
| MicroPort Orthopedics Global Supply Center Limited | Shanghai | Shanghai | Contract manufacturer | 82 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EML |
| Device type | Chisel, Bone, Surgical |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-19 |
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 |
|---|---|---|
| CHC36-37 | In distribution | |
| CHCP3-4 | In distribution | |
| CHCO2 | In distribution | |
| CHCO1 | In distribution | |
| CHC13K-TG | In distribution | |
| CHS13K-13KL | In distribution | |
| MXSP9 | In distribution | |
| MXSP6 | In distribution | |
| CHBC1 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 71 |
| Quinelato | Schobell Industrial Ltda | 55 |
| Stoma® | Storz AM Mark Gmbh | 33 |
| devemed | Devemed Gmbh | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| Power Dental USA | Power Dental U.S.A. Inc. | 24 |
| J & J Instruments | J & J Instruments, LLC | 17 |
| Millennium | Avalign Technologies, Inc. | 16 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 16 |
| Nordent Manufacturing, Inc. | Nordent Manufacturing Inc | 15 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 14 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 14 |
Showing 12 of 50. All products under Chisel, Bone, 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.