American Eagle Instruments
Burnisher 26-30 BF TN (3/8 SS)
17manufacturers in China registered for this device type
30catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (5), Shanghai (4), Jiangsu (3). One is registered as a contract manufacturer, able to build to a specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Shenzhen Denco Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 52 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Wuxi Lyusmile IMP AND EXP Co., Ltd. | Wuxi | Jiangsu | Private-label distributor | 66 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| CDM Center OF Excellence Ltd. | Beijing | Beijing | Manufacturer | 29 |
| Guilin Woodpecker Medical Instrument Co., Ltd. | Guilin | Guangxi | Manufacturer | 25 |
| Huizhou Videya Technology Co., Ltd. | Huizhou | Guangdong | Manufacturer | 18 |
| Gavin Biotechnology Co., Ltd. | Jinzhong | Shanxi | Manufacturer | 16 |
| Henan Lusterdent Medical Instrument Co., Ltd. | Zhengzhou | Henan | Manufacturer | 15 |
Showing 12 of 17. All 17 manufacturers in China registered for Spreader, Pulp Canal Filling Material, Endodontic
Record
| Listed by | American Eagle Instruments, United States |
|---|---|
| FDA product code | EKK |
| Device type | Spreader, Pulp Canal Filling Material, 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 | 2022-10-05 (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 |
|---|---|---|
| AEED11T-25S | In distribution | |
| AEED11T-21S | In distribution | |
| AEFO10-11 | In distribution | |
| AEB21BA | In distribution | |
| AEBJ | In distribution | |
| AEPBP-2 | In distribution | |
| AEBPFI21A | In distribution | |
| AEFH5-11 | In distribution | |
| AEBM1TN | In distribution | |
| AEB26-30BFTNZ | In distribution | |
| AEED11-21S | In distribution | |
| AEBL3 | In distribution | |
| AEMCB21ATNZ | In distribution | |
| AEBM1TNZ | In distribution | |
| AEFH3-7 | In distribution | |
| AEBPFI18B | In distribution | |
| AEBPP18 | In distribution | |
| AEB26-27B | In distribution | |
| AEB26-29BF | In distribution | |
| AEBH6 | In distribution | |
| AEE3-5P | In distribution | |
| AEBNYUB-1 | In distribution | |
| AEBH7 | In distribution | |
| AEB26-30BF | In distribution | |
| AEB26-28BF | In distribution | |
| AEB26-30BFTN | In distribution | |
| AEPPA | In distribution | |
| AEBPP19 | In distribution | |
| AEB2-30BEF | In distribution | |
| AEFO12-13 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| HU-Friedy | HU-Friedy MFG Co., LLC | 51 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 33 |
| Pluggers | Diadent Group Intl., Inc. | 32 |
| Spreaders | Diadent Group Intl., Inc. | 32 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 30 |
| 3D Endo | 3D Dental Designs AND Development, LLC | 30 |
| Mani Spreaders | Mani, Inc. | 15 |
| Spreaders | FKG Dentaire Sàrl | 14 |
| Premier Spreader | Premier Dental Products Co. | 11 |
| Henry Schein | Henry Schein, Inc. | 10 |
| Tapered Finger Spreader NiTi | Maillefer Instruments Holding Sàrl | 10 |
Showing 12 of 40. All products under Spreader, Pulp Canal Filling Material, 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.