American Eagle Instruments
Mopper Super Plugger SM-MED TN (3/8 SS)
19manufacturers in China registered for this device type
33catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (5), Jiangsu (5), Guangdong (3). 2 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 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Denjoy Dental Co., Ltd. | Changsha | Hunan | Contract manufacturer | 17 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
Showing 12 of 19. All 19 manufacturers in China registered for Plugger, Root Canal, Endodontic
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EKR |
| Device type | Plugger, Root Canal, Endodontic |
| 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 | 2024-04-15 (version 5) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Dry Heat Sterilization |
| Single use | Yes |
| Label carries | lot or batch number |
| Distribution end date | 2024-04-12 |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| AEE1-3P | In distribution | |
| AEC/P3T | In distribution | |
| AEE5-7P | In distribution | |
| AEE9-11P | In distribution | |
| AEC/PH1 | In distribution | |
| AEC/PSPML | In distribution | |
| AEC/PMN1 | In distribution | |
| AEC/POR1 | In distribution | |
| AEC/PSPSM | In distribution | |
| AEC/P11-12 | In distribution | |
| AEC/P2T | In distribution | |
| AEC/P9-10 | In distribution | |
| AEC/PH2 | In distribution | |
| AECP170 | In distribution | |
| AEC/PMCD2 | In distribution | |
| AEC/PMSPSMTNZ | In distribution | |
| AEC/PMSPMLTNZ | In distribution | |
| AEC/PSPSMRTNZ | In distribution | |
| AEC/PMSPSMTN | In distribution | |
| AEC/POR3 | In distribution | |
| AEMCC/P0TNZ | In distribution | |
| AEC/P1-2 | In distribution | |
| AEC/PMCD1 | In distribution | |
| AEMCC/P1TNZ | In distribution | |
| AEC/PC5A | In distribution | |
| AEC/PMCD3 | In distribution | |
| AEC/PO | In distribution | |
| AEC/POR1Z | In distribution | |
| AEC/P3-4 | In distribution | |
| AEC/POR2 | In distribution | |
| AEMCC/P2TNZ | In distribution | |
| AEC/PMSPMLTN | In distribution | |
| AEC/POR4 | Withdrawn |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 268 |
| Brasseler USA | Peter Brasseler Holdings, LLC | 93 |
| Power Dental USA | Power Dental U.S.A. Inc. | 82 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| Needle | B&L Biotech Co., Inc. | 40 |
| Henry Schein | Henry Schein, Inc. | 33 |
| Premier Pluggers | Premier Dental Products Co. | 29 |
| EQ-V | Meta Systems Co., Ltd. | 26 |
| Obtura Spartan | Young Innovations Inc. | 25 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 22 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 22 |
| Edge Endo | Handpiece Parts & Repairs, Inc. | 21 |
Showing 12 of 136. All products under Plugger, Root Canal, Endodontic
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.