Brasseler USA

HG1000TB25S Triple BEND#1000 1P US Insert

Registry build 21.09.26
14manufacturers in China registered for this device type
45catalogue numbers in this listing

Who Else Makes It

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

Chinese manufacturers registered for FDA product code ELC
Manufacturer City Province Registered as Device types
Zibo Dante Co., Ltd. Zibo Shandong Contract manufacturer 17
China Zhong YAN Chang Xing International Co., Ltd. Zibo Shandong Contract manufacturer 5
Lakong Medical Devices Co., Ltd. Dongguan Guangdong Remanufacturer 39
Guilin Woodpecker Medical Instrument Co., Ltd. Guilin Guangxi Manufacturer 25
Foshan Coxo Medical Instrument Co., Ltd. Foshan Guangdong Manufacturer 19
Denjoy Dental Co., Ltd. Changsha Hunan Contract manufacturer 17
Wenzhou Baiyu Glasses Technology Co., Ltd. Wenzhou Zhejiang Contract manufacturer 10
Shenzhen Ainengke Electronics Co., Ltd. Shenzhen Guangdong Manufacturer 9
Guilin Refine Medical Instrument Co., Ltd. Guilin Guangxi Contract manufacturer 7
Shenzhen Micro Electric Intelligence Co., Ltd. Shenzhen Guangdong Manufacturer 7
Changzhou Bomedent Medical Technology Co., Ltd. Changzhou Jiangsu Contract manufacturer 6
Nanning Baolai Medical Instrument Co., Ltd. Nanning Guangxi Manufacturer 4

Showing 12 of 14. All 14 manufacturers in China registered for Scaler, Ultrasonic

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code ELC
Device type Scaler, Ultrasonic
Device class Class 2
Regulation 21 CFR 872.4850
Record published 2016-09-14
Record revised 2023-01-19 (version 3)

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, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
5023152U0 In distribution
5023956U0 In distribution
5024339U0 In distribution
5023948U0 In distribution
5019437U0 In distribution
5019432U0 In distribution
5023963U0 In distribution
5023950U0 In distribution
5023153U0 In distribution
5023954U0 In distribution
5019435U0 In distribution
5019439U0 In distribution
5023969U0 In distribution
5019427U0 In distribution
5023970U0 In distribution
5024337U0 In distribution
5023958U0 In distribution
5023949U0 In distribution
5023959U0 In distribution
5023961U0 In distribution
5023962U0 In distribution
5024406U0 In distribution
5023966U0 In distribution
5023964U0 In distribution
5024338U0 In distribution
5024340U0 In distribution
5019426U0 In distribution
5023952U0 In distribution
5023951U0 In distribution
5023955U0 In distribution
5019428U0 In distribution
5019430U0 In distribution
5023957U0 In distribution
5019431U0 In distribution
5019438U0 In distribution
5023953U0 In distribution
5023960U0 In distribution
5023965U0 In distribution
5019433U0 In distribution
5019429U0 In distribution
5023967U0 In distribution
5023947U0 In distribution
5023968U0 In distribution
5019434U0 In distribution
5019436U0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Woodpecker Guilin Woodpecker Medical Instrument Co., Ltd. 501
Piezon E.M.S. Electro Medical Systems S.A. 245
Acteon Satelec 236
Mectron Mectron SPA 209
Varios Nakanishi Inc. 158
BioSonic Coltene/Whaledent Gmbh & Co. KG 142
Cavitron® Dentsply Professional 137
DTE Guilin Woodpecker Medical Instrument Co., Ltd. 113
Hu-Friedy HU-Friedy MFG Co., LLC 83
Obtura Spartan Obtura Spartan Endodontics 74
Henry Schein Henry Schein, Inc. 48
Baolai Nanning Baolai Medical Instrument Co., Ltd. 46

Showing 12 of 653. All products under Scaler, Ultrasonic

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