Brasseler USA
SW2 Whiteside Scal SE #2 HDL 1P
34manufacturers in China registered for this device type
40catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (15), Shandong (5), Shanghai (3). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.
| Manufacturer | City | Province | Registered as | Device types |
|---|---|---|---|---|
| Hangzhou Rollmed Co., Ltd. | Hangzhou | Zhejiang | Contract manufacturer | 127 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| Yangzhou Haiwang Toothbrush Factory | Yangzhou | Jiangsu | Contract manufacturer | 12 |
| Coda Resources Ltd., Heze China | Heze | Shandong | Contract manufacturer | 9 |
| Perfect Group Corp. Ltd. | Yangzhou | Jiangsu | Contract manufacturer | 9 |
| Shanghai Medical Instruments (Group) Ltd. Corp. | Shanghai | Shanghai | Contract manufacturer | 235 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Shanghai Kangqiao Dental Instruments Factory | Shanghai | Shanghai | Manufacturer | 54 |
| Lakong Medical Devices Co., Ltd. | Dongguan | Guangdong | Remanufacturer | 39 |
| Tangshan Zhengtong Exhibition Co., Ltd. | Tangshan | Hebei | Manufacturer | 34 |
| Guilin Yikeshi Medical Device Co Ltd | Guilin | Guangxi | Manufacturer | 28 |
| Shenzhen Balinda Technology Co., Ltd. | Shenzhen | Guangdong | Manufacturer | 23 |
Showing 12 of 34. All 34 manufacturers in China registered for Scaler, Periodontic
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | EMN |
| Device type | Scaler, Periodontic |
| 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 |
| Label carries | lot or batch number, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 5023455U0 | In distribution | |
| 5023460U0 | In distribution | |
| 5023459U0 | In distribution | |
| 5023409U0 | In distribution | |
| 5023458U0 | In distribution | |
| 5023257U0 | In distribution | |
| 5023453U0 | In distribution | |
| 5025460U0 | In distribution | |
| 5023424U0 | In distribution | |
| 5023444U0 | In distribution | |
| 5023421U0 | In distribution | |
| 5023443U0 | In distribution | |
| 5023334U0 | In distribution | |
| 5023329U0 | In distribution | |
| 5023457U0 | In distribution | |
| 5023442U0 | In distribution | |
| 5023406U0 | In distribution | |
| 5023420U0 | In distribution | |
| 5023413U0 | In distribution | |
| 5023419U0 | In distribution | |
| 5023407U0 | In distribution | |
| 5023405U0 | In distribution | |
| 5023328U0 | In distribution | |
| 5023456U0 | In distribution | |
| 5023462U0 | In distribution | |
| 5023411U0 | In distribution | |
| 5023330U0 | In distribution | |
| 5023335U0 | In distribution | |
| 5023333U0 | In distribution | |
| 5023423U0 | In distribution | |
| 5023415U0 | In distribution | |
| 5023410U0 | In distribution | |
| 5023454U0 | In distribution | |
| 5023331U0 | In distribution | |
| 5023327U0 | In distribution | |
| 5023416U0 | In distribution | |
| 5023412U0 | In distribution | |
| 5023414U0 | In distribution | |
| 5023446U0 | In distribution | |
| 5023408U0 | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| Hu-Friedy MFG Co., LLC. | HU-Friedy MFG Co., LLC | 468 |
| American Eagle Instruments | American Eagle Instruments | 269 |
| Zoll-Dental | Zoll-Dental | 255 |
| Hu-Friedy | HU-Friedy MFG Co., LLC | 207 |
| Power Dental USA | Power Dental U.S.A. Inc. | 202 |
| Osung MND | Osung MND Co., Ltd. | 102 |
| Helmut Zepf | Helmut Zepf Medizintechnik Gmbh | 85 |
| Sklar® | Sklar Corporation | 81 |
| Henry Schein | Henry Schein, Inc. | 79 |
| Integra® Miltex® | Integra LifeSciences Production Corporation | 77 |
| PDT, Inc. | PDT, Inc. | 67 |
| House Brand Dentistry | Frontier Dental Supply Inc | 65 |
Showing 12 of 216. All products under Scaler, Periodontic
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.