Brasseler USA

BRIO440L Highspeed Refurbished

Registry build 21.09.26
10manufacturers in China registered for this device type
76catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (7), Guangxi (1), Shaanxi (1).

Chinese manufacturers registered for FDA product code EFB
Manufacturer City Province Registered as Device types
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Foshan Cicada Dental Instrument Co., Ltd. Foshan Guangdong Manufacturer 15
Guangdong Jinme Medical Technology Co., Ltd. Foshan Guangdong Manufacturer 13
Sinol Dental Limited Xianyang Shaanxi Manufacturer 5
Foshan Soco Precision Instrument Co., Ltd. Foshan Guangdong Manufacturer 4
Shanghai Dental Instrument Factory Co., Ltd. Shanghai Shanghai Manufacturer 3
Foshan Topmed Dental Co., Ltd. Foshan Guangdong Manufacturer 2
Foshan Wenjian Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 2
Litu Tech Ltd. Zhongshan Guangdong Manufacturer 1

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code EFB
Device type Handpiece, Air-Powered, Dental
Device class Class 1
Regulation 21 CFR 872.4200
Record published 2022-12-07
Record revised 2022-12-07 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Supplied sterile Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date, serial number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
5028521U0 In distribution
5027001U0 In distribution
5026480U0 In distribution
5021266U0 In distribution
5028511U0 In distribution
5021263U0 In distribution
5029811U0 In distribution
5028516U0 In distribution
5028515U0 In distribution
5021316U0 In distribution
5028522U0 In distribution
5027990U0 In distribution
5028530U0 In distribution
5026765U0 In distribution
5028523U0 In distribution
5028208U0 In distribution
5028526U0 In distribution
5026059RF In distribution
5027293U0 In distribution
5021970U0 In distribution
5027992RF In distribution
5022751U0 In distribution
5026766U0 In distribution
5027003U0 In distribution
5027294U0 In distribution
5028528U0 In distribution
5026058RF In distribution
5027001RF In distribution
5021283U0 In distribution
5028519U0 In distribution
5028529U0 In distribution
5029833U0 In distribution
5028531U0 In distribution
5028210U0 In distribution
5021272U0 In distribution
151201-B In distribution
5028514U0 In distribution
5029832U0 In distribution
5027003RF In distribution
5027989RF In distribution
5029812U0 In distribution
5028518U0 In distribution
5021265U0 In distribution
5026479RF In distribution
5028532U0 In distribution
5021264U0 In distribution
5021281U0 In distribution
5026480RF In distribution
5021284U0 In distribution
5021318U0 In distribution
5026764U0 In distribution
5026059U0 In distribution
5027002RF In distribution
5021282U0 In distribution
5026058U0 In distribution
5027991RF In distribution
5021321U0 In distribution
5029834U0 In distribution
5026479U0 In distribution
5029813U0 In distribution
5021261U0 In distribution
5027294RF In distribution
5028527U0 In distribution
5027293RF In distribution
5028520U0 In distribution
5025051U0 In distribution
5021274U0 In distribution
5026767U0 In distribution
5028512U0 In distribution
5027002U0 In distribution
5021278U0 In distribution
5028524U0 In distribution
5021262U0 In distribution
5021760U0 In distribution
5028517U0 In distribution
5028525U0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
AIR-Flow E.M.S. Electro Medical Systems S.A. 220
Lares Research Lares Research 130
MK-dent MK-dent GmbH 129
Vector R&D, Inc Vector R&D, Inc. 114
MK-dent Germany® MK-dent GmbH 112
Johnson-Promident Young Innovations Inc. 92
Airlight Beyes Dental Canada, Inc. 65
Henry Schein Henry Schein, Inc. 62
MicroP Dental Microp Technology (Taiwan), Inc. 51
StarDental Instrument Solutions Dentalez, Inc. 47
Air-Driven Dental Handpieces MDK Co., Ltd. 39
Maxso Beyes Dental Canada, Inc. 38

Showing 12 of 968. All products under Handpiece, Air-Powered, 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.

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