Brasseler USA

5847.33.012 Fgss (SC) FLT TP 5P

Registry build 21.09.26
7manufacturers in China registered for this device type
2,016catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (5), Jiangsu (1), Henan (1). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code DZP
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
Huizhou Videya Technology Co., Ltd. Huizhou Guangdong Manufacturer 18
Shenzhen Superline Technology Co., Ltd. Shenzhen Guangdong Contract manufacturer 12
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9
Deprag High Tech Materials ( Zhengzhou ) Co., Ltd. Zhangzhou Henan Manufacturer 6

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code DZP
Device type Instrument, Diamond, Dental
Device class Class 1
Regulation 21 CFR 872.4535
Premarket notification Exempt
Record published 2022-12-07
Record revised 2023-07-18 (version 2)

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
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Showing 250 of 300 catalogue numbers.

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
MDT Diamond Coated Dental Burs M.D.T. – Micro Diamond Technologies Ltd. 31,050
MDT Diamond Coated Dental Burs -Sterile M.D.T. – Micro Diamond Technologies Ltd. 3,719
FG diamond DFS-Diamon Gmbh 2,527
Horico Hopf, Ringleb & Co. Gmbh & CIE. 2,320
Two Striper Abrasive Technology, LLC 2,294
Sunshine Diamonds DR. Hopf Gmbh & Co. KG 2,240
Edenta Edenta Etablissement 1,831
Instrument, Diamond, Dental Hager & Meisinger Gesellschaft mit beschränkter Haftung 1,827
Jota Jota AG 1,615
Komet Dental Diamond Instruments Gebr. Brasseler Gmbh & Co. KG 1,610
dental diamond bur Strauss & Co – Industrial Diamonds Ltd 1,456
NTI NTI-Kahla Gmbh, Rotary Dental Instruments 1,014

Showing 12 of 366. All products under Instrument, Diamond, 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