Power Dental USA
ORTHODONTIC, EXP23 I/8 / EXP6 5.3 mm I/8
8manufacturers in China registered for this device type
42catalogue numbers in this listing
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 | Power Dental U.S.A. Inc. |
|---|---|
| FDA product code | EKB |
| Device type | Explorer, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2021-06-20 |
| Record revised | 2025-04-28 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Latex | Labelled latex-free |
| Distribution end date | 2023-03-01 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 1012 | In distribution | |
| 5889 | In distribution | |
| 1010E | In distribution | |
| 1029 | In distribution | |
| 1023E | In distribution | |
| 1006FS | In distribution | |
| 1007E | In distribution | |
| 1006F | In distribution | |
| 1021 | In distribution | |
| 1005 | In distribution | |
| 9020-EXAM | In distribution | |
| 1017 | In distribution | |
| 1018 | In distribution | |
| 1006L | In distribution | |
| 1011E | In distribution | |
| 1019E | In distribution | |
| 1019 | In distribution | |
| 1021E | In distribution | |
| 1009 | In distribution | |
| 1013 | In distribution | |
| 1017E | In distribution | |
| 1026 | In distribution | |
| 1023 | In distribution | |
| 1022 | In distribution | |
| 1012E | In distribution | |
| 1014 | In distribution | |
| 1015E | In distribution | |
| 1010 | In distribution | |
| 1009E | In distribution | |
| 1020 | In distribution | |
| 1026E | In distribution | |
| 1007 | In distribution | |
| 1006 | In distribution | |
| 1011 | In distribution | |
| 1015 | In distribution | |
| 1006E | In distribution | |
| 1014E | In distribution | |
| 1005E | In distribution | |
| 1018E | In distribution | |
| 1022E | In distribution | |
| 1022 | Withdrawn | |
| 1026 | Withdrawn |
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 |
| 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 |
| Burkhart Dental | Nordent Manufacturing Inc | 25 |
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.