Mirror, Mouth
3 catalogue numbers from 09-0590, listed by Biomet Microfixation, United States, under Mirror, Mouth. 94 manufacturers in China are registered for this product code.
94manufacturers in China registered for this device type
3catalogue numbers in this listing
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 | Biomet Microfixation, United States |
|---|---|
| FDA product code | EAX |
| Device type | Mirror, Mouth |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Specification developer, Repacker / relabeller, Complaint-file establishment, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2018-08-23 |
| Record revised | 2025-05-30 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 09-0590 | In distribution | |
| 09-0589 | In distribution | |
| 09-0595 | 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 |
| Osung MND | Osung MND Co., Ltd. | 39 |
| Mouth Mirror Handle | Zirc Dental Products, Inc. | 33 |
| Jedmed | Jedmed Instrument Company | 31 |
| Plasdent | Plasdent Corp. | 30 |
| Henry Schein | Henry Schein, Inc. | 27 |
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.