Osung MND
A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental…
A manual dental device in the form of a strip coated with abrasive particles on one or both sides intended to be used for modifying the surface of a tooth or restoration during a dental procedure. It is commonly known as a polishing strip. This is a single-use device.
Who Else Makes It
Concentrated in Guangdong (7), Zhejiang (2), Jiangsu (2). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Huanghua Promisee Dental Co., Ltd. | Huanghua | Hebei | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Henan Baistra Medical Devices Limited | Zhengzhou | Henan | Manufacturer | 34 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Hangzhou Wise Medical Device Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 25 |
| Unisource Shanghai Ltd. | Shanghai | Shanghai | Reprocessor | 23 |
| Llrn Personal Care (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 20 |
| Guangxi Ehall Medical Technology Co., Ltd. | Nanning | Guangxi | Manufacturer | 17 |
| Changsha Easyinsmile Intelligence Technology Co., Ltd. | Changsha | Hunan | Manufacturer | 15 |
Showing 12 of 18. All 18 manufacturers in China registered for Strip, Polishing Agent
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EHM |
| Device type | Strip, Polishing Agent |
| Device class | Class 1 |
| Regulation | 21 CFR 872.6010 |
| 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 |
|---|---|---|
| SRTVD60 | In distribution | |
| SRTVD15 | In distribution | |
| SRTVD60H | In distribution | |
| SRTVD90H | In distribution | |
| SRTVD25H | In distribution | |
| SRTVD25 | In distribution | |
| SRTVD40H | In distribution | |
| SRTVD15H | In distribution | |
| SRTVD90 | In distribution | |
| SRTVD40 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Sunshine Diamonds | DR. Hopf Gmbh & Co. KG | 197 |
| Horico | Hopf, Ringleb & Co. Gmbh & CIE. | 146 |
| MDT Diamond Coated Dental Flexible Strips | M.D.T. – Micro Diamond Technologies Ltd. | 121 |
| ContacEZ | Directa AB | 104 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 95 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| Galaxy™ | Ortho Organizers, Inc. | 47 |
| NEW Metal Strips | GC America Inc. | 34 |
| SpaceFile® | Dentsply Sirona Orthodontics Inc. | 29 |
| Microdont | 3R – Industria E Comercio Eireli | 28 |
| Two Striper | Abrasive Technology, LLC | 21 |
| Denfinity | 3R – Industria E Comercio Eireli | 21 |
Showing 12 of 83. All products under Strip, Polishing Agent
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.