Osung MND
A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or…
A non-electric, hand-held dental instrument intended to be used to remove a permanent or temporary cemented dental prosthesis restoration (e.g., crown, denture, bridge) from a tooth or implant abutment; it is not a thermal detacher. It consists of a metallic instrument with a handle and a pointed, angled distal end used to secure the instrument at the margin of the prosthesis to be removed; it may be designed as a manual, pneumatic or spring-loaded instrument whereby light force is applied to detach the restoration. This is a reusable device.
Who Else Makes It
Concentrated in Shanghai (2), Guangxi (1), Shandong (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shandong Hengfeng Kerui Medical Equipment Co., Ltd. | Qingdao | Shandong | Contract manufacturer | 19 |
| Foshan Cicada Dental Instrument Co., Ltd. | Foshan | Guangdong | Manufacturer | 15 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EIS |
| Device type | Remover, Crown |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2025-11-03 |
| 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 |
|---|---|---|
| CFRT85 | In distribution | |
| CF02 | In distribution | |
| 3RECDB | In distribution | |
| CF01 | In distribution | |
| 4RECDA | In distribution | |
| 4RECDB | In distribution | |
| CFP5 | In distribution | |
| RECR3SKIT | In distribution | |
| CG01 | In distribution | |
| 3RECDA | In distribution | |
| CFRT85 | Withdrawn | |
| CFP5 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| devemed | Devemed Gmbh | 35 |
| Zoll-Dental | Zoll-Dental | 25 |
| Reicodent | Devemed Gmbh | 25 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 20 |
| Paul Banditt | Terlain Enterprises, Inc. | 16 |
| Stoma® | Storz AM Mark Gmbh | 13 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 11 |
| Karl Schumacher | Karl Schumacher Dental, LLC | 11 |
| Schwert | A. Schweickhardt Gmbh & Co. KG | 9 |
| Kohdent | Kohler Medizintechnik GmbH | 9 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 8 |
Showing 12 of 59. All products under Remover, Crown
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.