Osung MND
An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for…
An insert intended to be attached to an ultrasonic dental scaling/debridement system handpiece, to transmit ultrasonic energy (e.g., 25 kHz/30 kHz) from a generator to the oral cavity for the removal of accretions from tooth surfaces during dental cleaning or periodontal therapy; it is not intended for endodontic use. This device vibrates at a high frequency to provide the scaling effect. Water or a rinsing solution (e.g., chlorhexidine) is intended to be fed through the handpiece/tip assembly to assist in the process. This device is available in a variety of designs and tip shapes. This is a reusable device.
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| 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 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-03-04 |
| 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 |
|---|---|---|
| CGR5-6 | In distribution | |
| LSJAC30-33 | In distribution | |
| 2CGR3-4 | In distribution | |
| 2CMGR1-2 | In distribution | |
| HSL34-35 | In distribution | |
| 2CGR13-14 | In distribution | |
| LS204 | In distribution | |
| 2CLGR13-14 | In distribution | |
| USS1 | In distribution | |
| CRGR11-12 | In distribution | |
| 2CLGR11-12 | In distribution | |
| CSZ | In distribution | |
| Diagnostic&Supragingival Scaling | In distribution | |
| CGR1-2 | In distribution | |
| CGR15-16 | In distribution | |
| 3CGR13-14 | In distribution | |
| 3LSK02 | In distribution | |
| 2CLGR7-8 | In distribution | |
| CMGR3-4 | In distribution | |
| 2CGR7-8 | In distribution | |
| 3CGR5-6 | In distribution | |
| 2CMGR5-6 | In distribution | |
| 3LSK01 | In distribution | |
| LSJAC31-32 | In distribution | |
| CGR11-12 | In distribution | |
| ICGR1-2 | In distribution | |
| ICGR13-14 | In distribution | |
| 3CRGR9-10 | In distribution | |
| HSO8-9 | In distribution | |
| CMGR13-14 | In distribution | |
| 3CGR7-8 | In distribution | |
| 2LSJAC34-35 | In distribution | |
| ICGR11-12 | In distribution | |
| CRGR13-14 | In distribution | |
| LSMS1-2 | In distribution | |
| 2CGR15-16 | In distribution | |
| 3CRGR1-2 | In distribution | |
| 2LSMS1-2 | In distribution | |
| 2LSH5-33 | In distribution | |
| 3CRGR7-8 | In distribution | |
| 3CRGR5-6 | In distribution | |
| 2LSH6-H7 | In distribution | |
| 2CGR1-2 | In distribution | |
| 2CLGR1-2 | In distribution | |
| 2CMGR11-12 | In distribution | |
| LSH6-H7 | In distribution | |
| LS204S | In distribution | |
| 2LSJAC30-33 | In distribution | |
| CRGR3-4 | In distribution | |
| 3CRGR11-12 | In distribution | |
| 3CGR11-12 | In distribution | |
| LSH5-33 | In distribution | |
| 2CMGR3-4 | In distribution | |
| 3CGR3-4 | In distribution | |
| 3CRGR13-14 | In distribution | |
| CRGR9-10 | In distribution | |
| 2CLGR9-10 | In distribution | |
| 2CMGR13-14 | In distribution | |
| 2CMGR9-10 | In distribution | |
| CMGR5-6 | In distribution | |
| HSP56-57 | In distribution | |
| 3CGR17-18 | In distribution | |
| HSA12-13 | In distribution | |
| 2LSJAC31-32 | In distribution | |
| CGR3-4 | In distribution | |
| USEA | In distribution | |
| 3LSJAC34-35 | In distribution | |
| CGR7-8 | In distribution | |
| 2CGR17-18 | In distribution | |
| 2CGR5-6 | In distribution | |
| 2LSMS11-12 | In distribution | |
| LS204SD | In distribution | |
| 3CGR15-16 | In distribution | |
| 2CLGR5-6 | In distribution | |
| 3CRGR3-4 | In distribution | |
| LSJAC34-35 | In distribution | |
| CRGR1-2 | In distribution | |
| CMGR11-12 | In distribution | |
| CMGR9-10 | In distribution | |
| ICGR7-8 | In distribution | |
| USEPS | In distribution | |
| 3CGR9-10 | In distribution | |
| LSU15-33 | In distribution | |
| 2CGR11-12 | In distribution | |
| ICGR5-6 | In distribution | |
| 3LSU15-33 | In distribution | |
| CMGR1-2 | In distribution | |
| LSU15-30 | In distribution | |
| CRGR5-6 | In distribution | |
| USEP | In distribution | |
| CGR17-18 | In distribution | |
| 2CLGR3-4 | In distribution | |
| LSMS11-12 | In distribution | |
| CRGR7-8 | In distribution | |
| 3CGR1-2 | In distribution | |
| CGR9-10 | In distribution | |
| CMGR7-8 | In distribution | |
| 2CGR9-10 | In distribution | |
| LSSCM152 | In distribution | |
| CGR13-14 | In distribution | |
| 2CMGR7-8 | In distribution | |
| USEA | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| American Eagle Instruments | American Eagle Instruments | 269 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| PDT, Inc. | PDT, Inc. | 67 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
| J & J Instruments | J & J Instruments, LLC | 56 |
Showing 12 of 216. All products under Scaler, Periodontic
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.