Brasseler USA
PL4/8PN PLG Cond PN W/ 2 HDL 1P
19manufacturers in China registered for this device type
93catalogue 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 | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EKR |
| Device type | Plugger, Root Canal, Endodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2026-03-24 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date, serial number |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5031780U0 | In distribution | |
| 5030808U0 | In distribution | |
| 5009754U0 | In distribution | |
| 5030823U0 | In distribution | |
| 5030799U0 | In distribution | |
| 5030830U0 | In distribution | |
| 5026158U0 | In distribution | |
| 5030801U0 | In distribution | |
| 5030815U0 | In distribution | |
| 5009753U0 | In distribution | |
| 5030820U0 | In distribution | |
| 5030819U0 | In distribution | |
| 5023657U0 | In distribution | |
| 5030807U0 | In distribution | |
| 5030804U0 | In distribution | |
| 5023643U0 | In distribution | |
| 5030832U0 | In distribution | |
| 5026159U0 | In distribution | |
| 5023637U0 | In distribution | |
| 5030802U0 | In distribution | |
| 5023551U0 | In distribution | |
| 5009518U0 | In distribution | |
| 5030810U0 | In distribution | |
| 5023560U0 | In distribution | |
| 5023563U0 | In distribution | |
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| 5026165U0 | In distribution | |
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| 5023647U0 | In distribution | |
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| 5026166U0 | In distribution | |
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| 5023554U0 | In distribution | |
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| 5023655U0 | In distribution | |
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| 5030826U0 | In distribution | |
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| 5030828U0 | In distribution | |
| 5023656U0 | In distribution | |
| 5023638U0 | In distribution | |
| 5030818U0 | In distribution | |
| 5023561U0 | In distribution | |
| 5030814U0 | In distribution | |
| 5023642U0 | In distribution | |
| 5030833U0 | In distribution | |
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| 5023552U0 | In distribution | |
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| 5024753U0 | In distribution | |
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| 5030919U0 | In distribution | |
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| 5023653U0 | In distribution | |
| 5009519U0 | In distribution | |
| 5026160U0 | In distribution | |
| 5023640U0 | In distribution | |
| 5030806U0 | In distribution | |
| 5023659U0 | In distribution | |
| 5023550U0 | In distribution | |
| 5024754U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| HU-Friedy | HU-Friedy MFG Co., LLC | 268 |
| Power Dental USA | Power Dental U.S.A. Inc. | 82 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 69 |
| Needle | B&L Biotech Co., Inc. | 40 |
| American Eagle Instruments | American Eagle Instruments | 33 |
| 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.