Brasseler USA
Dualforce Wedge #1 Purple 100PK
64manufacturers in China registered for this device type
67catalogue numbers in this listing
Who Else Makes It
Concentrated in Guangdong (17), Jiangsu (10), Hebei (5). 8 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 |
| Shenzhen Rogin Medical Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 51 |
| BH Medical Products Co., Ltd. | Changzhou | Jiangsu | Contract manufacturer | 37 |
| Shenzhen Senlede Technologies Co., Ltd. | Shenzhen | Guangdong | Contract manufacturer | 33 |
| Suzhou Pac-Dent Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 26 |
| iBrite Suzhou Technology Co., Ltd. | Suzhou | Jiangsu | Contract manufacturer | 18 |
| Acot Plastics (Xiamen) Co., Ltd. | Xiamen | Fujian | Contract manufacturer | 8 |
| medmix China Ltd | Shanghai | Shanghai | Contract manufacturer | 2 |
| Boen Healthcare Co., Ltd. | Suzhou | Jiangsu | Specification developer | 263 |
| Xinhua Surgical Instrument Co., Ltd. | Zibo | Shandong | Manufacturer | 222 |
| Debo Medical Technology (Shijiazhuang) Co., Ltd. | Shijiazhuang | Hebei | Contract manufacturer | 117 |
| Shanghai Jolly Industrial Co., Ltd. | Shanghai | Shanghai | Contract manufacturer | 99 |
Showing 12 of 64. All 64 manufacturers in China registered for Instruments, Dental Hand
Record
| Listed by | Peter Brasseler Holdings, LLC |
|---|---|
| FDA product code | DZN |
| Device type | Instruments, Dental Hand |
| Device class | Class 1 |
| Regulation | 21 CFR 872.4565 |
| Premarket notification | Exempt |
| Record published | 2023-01-31 |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Sterilisation | Moist Heat or Steam Sterilization |
| Supplied sterile | Yes |
| Single use | Yes |
| Prescription | Prescription only |
| Supplied as a kit | Yes |
| Label carries | lot or batch number, expiry date, manufacturing date |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 209001-B | In distribution | |
| 5031823U0 | In distribution | |
| 5023858U0 | In distribution | |
| 209024-B | In distribution | |
| 5031825U0 | In distribution | |
| 209007-B | In distribution | |
| 209008-B | In distribution | |
| 5024129U0 | In distribution | |
| 209020-B | In distribution | |
| 5023860U0 | In distribution | |
| 5023863U0 | In distribution | |
| 209022-B | In distribution | |
| 5024128U0 | In distribution | |
| 5023857U0 | In distribution | |
| 209000-B | In distribution | |
| 209004-B | In distribution | |
| 209023-B | In distribution | |
| 209002-B | In distribution | |
| 209006-B | In distribution | |
| 5025344U0 | In distribution | |
| 209005-B | In distribution | |
| 5031826U0 | In distribution | |
| 5023862U0 | In distribution | |
| 5025343U0 | In distribution | |
| 5014507U0 | In distribution | |
| 5031818U0 | In distribution | |
| 5013633U0 | In distribution | |
| 5013634U0 | In distribution | |
| 5023859U0 | In distribution | |
| 5031819U0 | In distribution | |
| 5010500U0 | In distribution | |
| 5023803U0 | In distribution | |
| 5022957U0 | In distribution | |
| 5022958U0 | In distribution | |
| 5022039U0 | In distribution | |
| 5014397U0 | In distribution | |
| 209003-B | In distribution | |
| 209019-B | In distribution | |
| 5023802U0 | In distribution | |
| 5011098U0 | In distribution | |
| 209013-B | In distribution | |
| 5023864U0 | In distribution | |
| 5026890U0 | In distribution | |
| 5023805U0 | In distribution | |
| 5023172U0 | In distribution | |
| 5023804U0 | In distribution | |
| 5023806U0 | In distribution | |
| 5024149U0 | In distribution | |
| 5025345U0 | In distribution | |
| 5023807U0 | In distribution | |
| 5024197U0 | In distribution | |
| 209016-B | In distribution | |
| 5022909U0 | In distribution | |
| 5015213U0 | In distribution | |
| 209009-B | In distribution | |
| 5013634U1 | In distribution | |
| 5023808U0 | In distribution | |
| 5023861U0 | In distribution | |
| 209018-B | In distribution | |
| 5027164U0 | In distribution | |
| 5022959U0 | In distribution | |
| 5031822U0 | In distribution | |
| 5024127U0 | In distribution | |
| 5024148U0 | In distribution | |
| 5023062U0 | In distribution | |
| 5023865U0 | In distribution | |
| 209021-B | In distribution |
Same Product Code
| Product | Sold by | Catalogue numbers |
|---|---|---|
| LMDental | LM-Dental | 936 |
| A. Titan Instruments | A. Titan Instruments, Inc. | 544 |
| Instruments, Dental Hand | Hager & Meisinger Gesellschaft mit beschränkter Haftung | 307 |
| Power Dental USA | Power Dental U.S.A. Inc. | 209 |
| Supremo Instrumentos | Andre Gregate Braga Instrumentos Ltda | 95 |
| Henry Schein | Henry Schein, Inc. | 93 |
| Neodent | Jjgc Indústria e Comércio de Materiais Dentários S.A. | 92 |
| Diamodent | Diamodent | 81 |
| Stoma® | Storz AM Mark Gmbh | 80 |
| Nordent Manufacturing Inc | Nordent Manufacturing Inc | 77 |
| BMT Medizintechnik GmbH | BMT Medizintechnik GmbH | 58 |
| Darby Dental Supply, LLC | Darby Dental Supply, LLC | 53 |
Showing 12 of 1,362. All products under Instruments, Dental Hand
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.