Brasseler USA

ESP7006 SEQ POST.70MM.06 Tape

Registry build 21.09.26
10manufacturers in China registered for this device type
44catalogue numbers in this listing

Who Else Makes It

Concentrated in Guangdong (3), Jiangsu (2), Shanghai (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 ELR
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
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Zogear Medical Co., Ltd. Yizheng Jiangsu Contract manufacturer 75
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Alwings Medical Instrument Co., Ltd. Shanghai Shanghai Manufacturer 39
Henan Lusterdent Medical Instrument Co., Ltd. Zhengzhou Henan Manufacturer 15
Shanghai Fanta Dental Materials Co., Ltd. Shanghai Shanghai Manufacturer 15
Shenzhen Forever Medical Devices Co., Ltd. Shenzhen Guangdong Contract manufacturer 9

Record

Regulatory record for Brasseler USA
Listed by Peter Brasseler Holdings, LLC
FDA product code ELR
Device type Post, Root Canal
Device class Class 1
Regulation 21 CFR 872.3810
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
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Brasseler USA
Catalogue number Size Status
5013511U0 In distribution
5013912U0 In distribution
5021713U0 In distribution
5013513U0 In distribution
5013508U0 In distribution
5015625U0 In distribution
5013509U0 In distribution
5013827U0 In distribution
5013910U0 In distribution
5013832U0 In distribution
5013823U0 In distribution
5013913U0 In distribution
5013512U0 In distribution
5013515U0 In distribution
5013514U0 In distribution
5013830U0 In distribution
5021711U0 In distribution
5013833U0 In distribution
5015623U0 In distribution
5013819U0 In distribution
5021712U0 In distribution
5013822U0 In distribution
5013831U0 In distribution
5013919U0 In distribution
5013911U0 In distribution
5013917U0 In distribution
5013909U0 In distribution
5013821U0 In distribution
5013835U0 In distribution
5015626U0 In distribution
5013916U0 In distribution
5013826U0 In distribution
5013510U0 In distribution
5013914U0 In distribution
5013828U0 In distribution
5013818U0 In distribution
5013825U0 In distribution
5013820U0 In distribution
5013829U0 In distribution
5013920U0 In distribution
5013915U0 In distribution
5013918U0 In distribution
5013834U0 In distribution
5013824U0 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Henry Schein Henry Schein, Inc. 115
ParaPost XP Coltene/Whaledent Gmbh & Co. KG 111
Darby Dental Supply, LLC Darby Dental Supply, LLC 90
Hahnenkratt E. Hahnenkratt Gmbh 89
Surtex Dentatus AB 84
ParaPost Coltene/Whaledent Gmbh & Co. KG 46
Two Striper Abrasive Technology, LLC 43
Johnson-Promident Young Innovations Inc. 41
Flexi-Post Essential Dental Systems, Inc. 40
Biolight Synca Marketing 37
Integra® Miltex® Integra LifeSciences Production Corporation 37
Endodontic Posts Rhein 83 SRL 31

Showing 12 of 231. All products under Post, Root Canal

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