American Orthodontics
AO SE Explorer 23
8manufacturers in China registered for this device type
1catalogue number
Who Else Makes It
Concentrated in Guangdong (4), Shanghai (2), Shandong (1). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Elite Dental LAB | Huizhou | Guangdong | Manufacturer | 18 |
| Shumei Industrial (Hebei) Co., Ltd. | Cangzhou | Hebei | Contract manufacturer | 10 |
| Guang Zhou Medclear Medical Device Service Co., Ltd. | Dongguan | Guangdong | Contract manufacturer | 9 |
| Pengbo (Shenzhen) Medical Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 6 |
Record
| Listed by | Nordent Manufacturing Inc |
|---|---|
| FDA product code | EKB |
| Device type | Explorer, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2020-04-28 |
| Record revised | 2023-01-20 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization, Moist Heat or Steam Sterilization |
| Single use | Yes |
| Label carries | lot or batch number, manufacturing date |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 010-009 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 207 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 196 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 86 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Power Dental USA | Power Dental U.S.A. Inc. | 42 |
| Sklar® | Sklar Corporation | 39 |
| Premier Explorers | Premier Dental Products Co. | 35 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 32 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 30 |
| Zoll-Dental | Zoll-Dental | 29 |
| National Distribution & Contracting Inc. | Nordent Manufacturing Inc | 28 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 26 |
Showing 12 of 77. All products under Explorer, Operative
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.