Brasseler USA

Dualforce Wedge #1 Purple 100PK

Registry build 21.09.26
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.

Chinese manufacturers registered for FDA product code DZN
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

Regulatory record for Brasseler USA
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

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 numbers for Brasseler USA
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

Other products under the same FDA 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.

Where China Actually Supplies

Every device page names the company that lists it and the factories registered to make the same thing. These are the sections with the most of them.

5,100manufacturers registered in China
2,581device types they are registered for
340,248device records, each naming its maker
31provinces with a registered manufacturer