Brasseler USA

183L.21.090 Peeso S/S Yellow 5P

Registry build 21.09.26
20manufacturers in China registered for this device type
47catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (6), Jiangsu (5), Anhui (2). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZA
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
Digital Dental Depot Zhuhai Guangdong Contract manufacturer 17
Shanghai Toboom Dental Techonology Co., Ltd. Shanghai Shanghai Contract manufacturer 10
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
TF NEW Material SCI AND TEC Co., Ltd. Huainan Anhui Manufacturer 51
Hefei Mlush Sanitary Products Co., Ltd. Hefei Anhui Manufacturer 48
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
CDM Center OF Excellence Ltd. Beijing Beijing Manufacturer 29
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Chengdu Besmile Medical Technology Co., Ltd. Chengdu Sichuan Manufacturer 14

Showing 12 of 20. All 20 manufacturers in China registered for Drill, Dental, Intraoral

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code DZA
Device type Drill, Dental, Intraoral
Device class Class 1
Regulation 21 CFR 872.4130
Premarket notification Exempt
Record published 2022-12-01

Specifications

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
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
011699U1 In distribution
011698U0 In distribution
5006755U1 In distribution
5006748U1 In distribution
018237U0 In distribution
5006757U0 In distribution
018229U1 In distribution
018231U0 In distribution
5017689U0 In distribution
5013655U0 In distribution
018232U0 In distribution
018233U0 In distribution
003113U0 In distribution
018231U1 In distribution
5006749U1 In distribution
5017691U0 In distribution
5006753U0 In distribution
018233U1 In distribution
5006760U0 In distribution
5006749U0 In distribution
018230U0 In distribution
5006755U0 In distribution
5017695U0 In distribution
5006747U0 In distribution
5006750U0 In distribution
018226U0 In distribution
5006756U1 In distribution
5006751U0 In distribution
5006756U0 In distribution
003688U0 In distribution
003687U0 In distribution
5006748U0 In distribution
018235U0 In distribution
5006758U0 In distribution
5017694U0 In distribution
018359U0 In distribution
5006754U0 In distribution
003689U0 In distribution
018228U0 In distribution
5017693U0 In distribution
003115U0 In distribution
018229U0 In distribution
5006752U0 In distribution
5017690U0 In distribution
003114U0 In distribution
5017692U0 In distribution
018227U0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Neobiotech Implant System Neobiotech Co., Ltd. 685
Jota Jota AG 307
OneGuide Taper Drill Osstem Implant Co., Ltd. 291
Neodent Jjgc Indústria e Comércio de Materiais Dentários S.A. 286
122 Taper Drill Osstem Implant Co., Ltd. 285
Taper Drill Osstem Implant Co., Ltd. 279
Edenta Edenta Etablissement 275
Bone Compaction Drill Osstem Implant Co., Ltd. 200
Dental Surgical Drill Cowellmedi Co., Ltd. 195
Twist Drill Osstem Implant Co., Ltd. 169
Bondent United Dental Changzhou 166
Ritter Implants Dental System Ritter Implants GmbH & Co. KG 156

Showing 12 of 875. All products under Drill, Dental, Intraoral

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