Brasseler USA
270145WS KF21MM 10-35AW/STOP 6P
10manufacturers in China registered for this device type
82catalogue numbers in this listing
Who Else Makes It
Concentrated in Shanghai (4), Guangdong (3), Anhui (1). 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 |
| Anqing Clean Dental Instrument Technology Co., Ltd. | Anqing | Anhui | Manufacturer | 50 |
| Dongguan Wanjin Industrial Co., Ltd. | Dongguang | Guangdong | Remanufacturer | 41 |
| Shanghai Smedent Medical Instrument Co., Ltd. | Shanghai | Shanghai | Repacker / relabeller | 30 |
| Jinyuan Medical Equipment(Tianjin)Co., Ltd. | Tianjin | Tianjin | Contract manufacturer | 27 |
| Bgss Company Asia Limited | Zhabei | Shanghai | Contract manufacturer | 25 |
| Shanghai Fanta Dental Materials Co., Ltd. | Shanghai | Shanghai | Manufacturer | 15 |
| Innovative Material & Devices, Inc. | Wuxi | Jiangsu | Contract manufacturer | 13 |
| Shenzhen Superline Technology Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 12 |
| Shanghai Toboom Dental Techonology Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 10 |
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EKP |
| Device type | Reamer, Pulp Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-01 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5007605U0 | In distribution | |
| 5011809U0 | In distribution | |
| 5007614U0 | In distribution | |
| 5007574U0 | In distribution | |
| 5007585U0 | In distribution | |
| 5007562U0 | In distribution | |
| 5007572U0 | In distribution | |
| 5007616U0 | In distribution | |
| 5007587U0 | In distribution | |
| 5011810U0 | In distribution | |
| 5007626U0 | In distribution | |
| 5009087U0 | In distribution | |
| 5011795U0 | In distribution | |
| 5018035U0 | In distribution | |
| 5007625U0 | In distribution | |
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| 5009025U0 | In distribution | |
| 5010772U0 | In distribution | |
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| 5007624U0 | In distribution | |
| 5011819U0 | In distribution | |
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| 5007577U0 | In distribution | |
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| 5009028U0 | In distribution | |
| 5011816U0 | In distribution | |
| 5010775U0 | In distribution | |
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| 5007621U0 | In distribution | |
| 5011804U0 | In distribution | |
| 5007607U0 | In distribution | |
| 5007586U0 | In distribution | |
| 5010770U0 | In distribution | |
| 5009026U0 | In distribution | |
| 5011797U0 | In distribution | |
| 5011793U0 | In distribution | |
| 5007619U0 | In distribution | |
| 5011825U0 | In distribution | |
| 5007610U0 | In distribution | |
| 5009085U0 | In distribution | |
| 5007617U0 | In distribution | |
| 5007559U0 | In distribution | |
| 5009086U0 | In distribution | |
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| 5011806U0 | In distribution | |
| 5007563U0 | In distribution | |
| 5007618U0 | In distribution | |
| 5007620U0 | In distribution | |
| 5009024U0 | In distribution | |
| 5007579U0 | In distribution | |
| 5011822U0 | In distribution | |
| 5007557U0 | In distribution | |
| 5007609U0 | In distribution | |
| 5018036U0 | In distribution | |
| 5007558U0 | In distribution | |
| 5011791U0 | In distribution | |
| 5010773U0 | In distribution | |
| 5007590U0 | In distribution | |
| 5007564U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Henry Schein | Henry Schein, Inc. | 133 |
| Mani Reamers | Mani, Inc. | 106 |
| K-Reamers | Tulsa Dental Products LLC | 103 |
| K-Reamers | Micro-Mega SA | 72 |
| M-access® K-Reamer | Maillefer Instruments Holding Sàrl | 69 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 67 |
| Mani Engine Reamers | Mani, Inc. | 64 |
| Optimum | Benco Dental Supply Co. | 60 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 60 |
| Endodontic Hand Instruments | Tulsa Dental Products LLC | 49 |
| SafeSiders | Essential Dental Systems, Inc. | 40 |
| Endodontic Hand Instruments | Roydent Dental Products, Inc. | 28 |
Showing 12 of 195. All products under Reamer, Pulp 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.