American Eagle Instruments
Excavator 38-39 (11.5-7-14)
5manufacturers in China registered for this device type
17catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (2), Shandong (1), Hubei (1).
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| 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 |
| Hubei Lanbin Medical Group Co., Ltd. | Xiaogan | Hubei | Contract manufacturer | 33 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EKC |
| Device type | Excavator, Dental, Operative |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Establishment | Contract manufacturer, Repacker / relabeller, Manufacturer |
| Premarket notification | Exempt |
| Record published | 2022-07-12 |
| Record revised | 2024-09-26 (version 4) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AEEXC38-39 | In distribution | |
| AEEXC17 | In distribution | |
| AEEXC74-75 | In distribution | |
| AEEXC42-43 | In distribution | |
| AEEXC64-65 | In distribution | |
| AEEXC18 | In distribution | |
| AEEXC66-67 | In distribution | |
| AEEXCE-1 | In distribution | |
| AEEXCE-2 | In distribution | |
| AEEXCE-3 | In distribution | |
| AEEXC40-41 | In distribution | |
| AEMCEXC6TNZ | In distribution | |
| AEEXC20 | In distribution | |
| AEEXC70-71 | In distribution | |
| AEEM31LEXC | In distribution | |
| AEEM33LEXC | In distribution | |
| AEEMG2 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 193 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 149 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 59 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 44 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 43 |
| Excavator Double Ended | Maillefer Instruments Holding Sàrl | 36 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 35 |
| Power Dental USA | Power Dental U.S.A. Inc. | 34 |
| Premier Excavators | Premier Dental Products Co. | 30 |
| Zoll-Dental | Zoll-Dental | 28 |
| Kohdent | Kohler Medizintechnik GmbH | 27 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 27 |
Showing 12 of 52. All products under Excavator, Dental, 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.