Osung MND
A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for…
A dental instrument designed to remove with precision a circular section of oral soft tissue (e.g., gum, palatal mucosa) during dental surgery, typically to allow access to a site for drilling and dental/orthodontic implant placement without the use of a scalpel. Sometimes referred to as a mucotome, it will typically be designed with a handle at the proximal end for manual operation or for mounting into a dental power tool (e.g., contra-angle low-speed drill handpiece), and have a cylindrical hollow tube-like head with a sharp cutting at the distal end. It is typically made of high-grade stainless steel. This is a reusable device.
Who Else Makes It
Registered in Shandong.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EME |
| Device type | Punch, Biopsy, Surgical |
| 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 |
|---|---|---|
| TPH45S | In distribution | |
| RDPN1P | In distribution | |
| TPH35C | In distribution | |
| TPH50S | In distribution | |
| TPH40C | In distribution | |
| TPH35S | In distribution | |
| TP50CJ | In distribution | |
| TPI40G | In distribution | |
| TP35 | In distribution | |
| TP40CJ | In distribution | |
| TP40 | In distribution | |
| TPI40 | In distribution | |
| RDPN1 | In distribution | |
| TP50 | In distribution | |
| TP45 | In distribution | |
| TPH45C | In distribution | |
| TPH40S | In distribution | |
| TPH50C | In distribution | |
| TPI50 | In distribution | |
| TPI50G | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 36 |
| Sklar Instruments | Sklar Corporation | 24 |
| Kohdent | Kohler Medizintechnik GmbH | 22 |
| Medline | Medline Industries, Inc. | 20 |
| Acu-Punch | Acuderm, Inc. | 17 |
| Gynex | Gynex Corporation | 13 |
| Exel Biopsy Punch | Exel Inc. | 11 |
| Shard | Applied Dental, Inc. | 9 |
| Biotanium | Basic Dental Implant Systems, Inc. | 7 |
| Punches, Nobel | Omnia Medical | 6 |
| Salvin Stainless Steel Multi-Use Rotary Tissue Punch – 4mm | Salvin Dental Specialties, LLC | 5 |
| Salvin Dental Specialties | Salvin Dental Specialties, LLC | 4 |
Showing 12 of 64. All products under Punch, Biopsy, 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.