Brasseler USA
EX23/POW4 Expro POW/23 #4HDL 1P
29manufacturers in China registered for this device type
89catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (9), Jiangsu (6), Shanghai (3). 6 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 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Amedcon Medical Technology (Shenzhen) Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 7 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Zogear Medical Co., Ltd. | Yizheng | Jiangsu | Contract manufacturer | 75 |
| Tribest Dental Products Co Ltd | Yangzhong | Jiangsu | Contract manufacturer | 58 |
| Shanghai Hua En Industrial Co Ltd | Shanghai | Shanghai | Contract manufacturer | 52 |
Showing 12 of 29. All 29 manufacturers in China registered for Handle, Instrument, Dental
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EJB |
| Device type | Handle, Instrument, Dental |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2022-12-08 |
| Record revised | 2023-08-10 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023698U0 | In distribution | |
| 5023699U0 | In distribution | |
| 5025264U0 | In distribution | |
| 5023816U0 | In distribution | |
| 5023685U0 | In distribution | |
| 5023691U0 | In distribution | |
| 5023625U0 | In distribution | |
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| 5023689U0 | In distribution | |
| 5023704U0 | In distribution | |
| 5023673U0 | In distribution | |
| 5028484U0 | In distribution | |
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| 5023693U0 | In distribution | |
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| 5025525U0 | In distribution | |
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| 5023326U0 | In distribution | |
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| 5023692U0 | In distribution | |
| 5028486U0 | In distribution | |
| 5023672U0 | In distribution | |
| 5024261U0 | In distribution | |
| 5026891U0 | In distribution | |
| 5013408U0 | In distribution | |
| 5023664U0 | In distribution | |
| 5024264U0 | In distribution | |
| 5023696U0 | In distribution | |
| 5023661U0 | In distribution | |
| 5023701U0 | In distribution | |
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| 5008117U1 | In distribution | |
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| 5024263U0 | In distribution | |
| 5023817U0 | In distribution | |
| 5023663U0 | In distribution | |
| 5023686U0 | In distribution | |
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| 5023716U0 | In distribution | |
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| 5023694U0 | In distribution | |
| 5028695U0 | In distribution | |
| 5023700U0 | In distribution | |
| 5023458U1 | In distribution | |
| 5013406U0 | In distribution | |
| 5023690U0 | In distribution | |
| 5023680U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 121 |
| Premium Plus | Premium Plus International Limited | 83 |
| Surgical Kit | Shinhung MST Co., Ltd. | 78 |
| Hahnenkratt | E. Hahnenkratt Gmbh | 59 |
| Bioclear Diamond Wedge | Bioclear Matrix Systems, LLC | 50 |
| Hygitech | Hygitech | 47 |
| Plasdent | Plasdent Corp. | 37 |
| Stoma® | Storz AM Mark Gmbh | 34 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 34 |
| LMDental | LM-Dental | 33 |
| Henry Schein | Henry Schein, Inc. | 32 |
| ACE | Ace Surgical Supply Co., Inc. | 28 |
Showing 12 of 221. All products under Handle, Instrument, Dental
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.