Schweickhardt

Short Flush CUT Distal END Cutter W/2EA O-Rings

Registry build 21.09.26
28manufacturers in China registered for this device type
35catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (13), Shanghai (5), Guangdong (4). 4 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code JEX
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
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Shanghai Dochem Industries Co., Ltd. Shanghai Shanghai Manufacturer 45
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17
Guangzhou OO Medical Scientific Limited Guangzhou Guangdong Manufacturer 17

Showing 12 of 28. All 28 manufacturers in China registered for Plier, Orthodontic

Record

Regulatory record for Schweickhardt
Listed by RMO, United States
FDA product code JEX
Device type Plier, Orthodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Contract manufacturer, Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2024-08-26

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for Schweickhardt
Catalogue number Size Per pack Status
I00035 In distribution
I00567 In distribution
I00549W 2 In distribution
I00201 In distribution
I00546 In distribution
I00568 In distribution
I00350 In distribution
I00161 In distribution
I00548 In distribution
I00364 2 In distribution
I01201 5 In distribution
I00110 In distribution
I00347 In distribution
I00200 In distribution
I00351 In distribution
A04159 In distribution
I00586 In distribution
I01200 In distribution
I00274 In distribution
I00364 2 In distribution
I00349 In distribution
I00137 In distribution
I01200 In distribution
I00111 In distribution
I00129 In distribution
I00139 In distribution
I00420 In distribution
I00357 10 In distribution
I00569 10 In distribution
I00114 In distribution
I00365 In distribution
I00001 In distribution
I00140 In distribution
I00153 In distribution
I00545 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Dentronix Coltene/Whaledent Gmbh & Co. KG 165
Pomee Pomee Corporation 117
Schwert A. Schweickhardt Gmbh & Co. KG 110
Leone SPA Leone SPA 104
Orthosource Orthosource, Inc. 103
Power Dental USA Power Dental U.S.A. Inc. 103
HU-Friedy HU-Friedy MFG Co., LLC 102
Henry Schein Henry Schein, Inc. 95
American Eagle Instruments American Eagle Instruments 87
BMT Medizintechnik GmbH BMT Medizintechnik GmbH 68
Plier, Orthodontic YDM Corporation 67
gSource Gsource, LLC. 64

Showing 12 of 219. All products under Plier, Orthodontic

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