Osung MND
A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the…
A hand-held, dental instrument intended to be used by a dentist for intraoral inspection or inspection and retraction. It typically consists of a stainless steel shaft terminating at the distal end in a small round mirror that is angled to the shaft. This is a reusable device.
Who Else Makes It
Concentrated in Guangdong (23), Shanghai (15), Jiangsu (14). 9 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Anqing Kangmingna Packaging Co., Ltd. | Anqing | Anhui | Contract manufacturer | 39 |
| Beijing Zksk Technology Co., Ltd. | Beijing | Beijing | Contract manufacturer | 38 |
| Shun SZE Industrial (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 22 |
| Sino-Vista Dental Instruments Co., Ltd. | Zibo | Shandong | Contract manufacturer | 15 |
| 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 |
| Dongguan Shun King Company Limited | Dongguan | Guangdong | Contract manufacturer | 4 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
Showing 12 of 94. All 94 manufacturers in China registered for Mirror, Mouth
Record
| Listed by | Osung MND Co., Ltd., South Korea |
|---|---|
| FDA product code | EAX |
| Device type | Mirror, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Manufacturer |
| Premarket notification | Exempt |
| Record published | 2024-02-26 |
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 |
|---|---|---|
| DMFPM | In distribution | |
| DMBFL | In distribution | |
| DMDSS4 | In distribution | |
| BDMHL | In distribution | |
| DMSS4 | In distribution | |
| DMAPA | In distribution | |
| DME3 | In distribution | |
| DMSS3 | In distribution | |
| DMPRA | In distribution | |
| DMFSS4 | In distribution | |
| BDMHM | In distribution | |
| DMCS3 | In distribution | |
| DME6G | In distribution | |
| BDMHLT | In distribution | |
| DMFCS5 | In distribution | |
| BDMHS | In distribution | |
| DMPRP | In distribution | |
| DME2G | In distribution | |
| DMCS5 | In distribution | |
| DMCS4 | In distribution | |
| DME3G | In distribution | |
| DMBFS | In distribution | |
| DMFEM | In distribution | |
| DME4G | In distribution | |
| DMFSS5 | In distribution | |
| DMPM | In distribution | |
| DME5 | In distribution | |
| DME1G | In distribution | |
| DMBFLT | In distribution | |
| DMEM | In distribution | |
| DMSS5 | In distribution | |
| DME1G | In distribution | |
| DME5G | In distribution | |
| DMS39 | In distribution | |
| DME4 | In distribution | |
| DMFCS4 | In distribution | |
| DME1 | In distribution | |
| DMDCS4 | In distribution | |
| DMBFM | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| E. Hahnenkratt GmbH | E. Hahnenkratt Gmbh | 118 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 108 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 86 |
| Crystal HD® Mouth Mirrors | Zirc Dental Products, Inc. | 65 |
| Sklar® | Sklar Corporation | 60 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 59 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 43 |
| Mouth Mirror Handle | Zirc Dental Products, Inc. | 33 |
| Jedmed | Jedmed Instrument Company | 31 |
| Plasdent | Plasdent Corp. | 30 |
| Henry Schein | Henry Schein, Inc. | 27 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 205. All products under Mirror, Mouth
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.