Dentronix

Original Shear- Hold Safety Mini-Size Distal END Cutter

Registry build 21.09.26
28manufacturers in China registered for this device type
165catalogue 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 Dentronix
Listed by Coltene/Whaledent Gmbh & Co. KG, Germany
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, Exporter
Premarket notification Exempt
Record published 2019-02-26
Record revised 2024-10-25 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Dry Heat Sterilization
Prescription Prescription only
Label carries lot or batch number
Distribution end date 2024-10-24

Catalogue Numbers

Catalogue numbers for Dentronix
Catalogue number Size Status
DSE205 Withdrawn
DSE204 Withdrawn
DSE270-.7 Withdrawn
DSE200 Withdrawn
DSE201SA Withdrawn
D205G Withdrawn
DE200SNT Withdrawn
DS131 Withdrawn
D204 Withdrawn
DE139 Withdrawn
D139 Withdrawn
D3125 Withdrawn
D208 Withdrawn
D110 Withdrawn
DE200S Withdrawn
DE502 Withdrawn
DSE104P Withdrawn
DE242 Withdrawn
D172 Withdrawn
DE104P Withdrawn
DSE105G Withdrawn
DS210 Withdrawn
DSE236 Withdrawn
DS110I Withdrawn
D105G Withdrawn
DS203 Withdrawn
DE201 Withdrawn
DS208 Withdrawn
DSE201A Withdrawn
DSE104 Withdrawn
D222NT Withdrawn
DS110 Withdrawn
DE200V Withdrawn
DSE201 Withdrawn
DS213 Withdrawn
DSE230N Withdrawn
DE160 Withdrawn
DS204 Withdrawn
DSE241 Withdrawn
D110I Withdrawn
D131 Withdrawn
DS207M Withdrawn
DE201ST Withdrawn
DSE213I Withdrawn
DE270-.7 Withdrawn
DE203 Withdrawn
D104 Withdrawn
DE270-1 Withdrawn
D161 Withdrawn
DSE261A Withdrawn
DSE139 Withdrawn
DSE502 Withdrawn
D213S Withdrawn
DS201ST Withdrawn
DS200F Withdrawn
DSE160 Withdrawn
D270-.5 Withdrawn
D172A Withdrawn
D260 Withdrawn
DS347SI Withdrawn
DSE200SNT Withdrawn
DE236 Withdrawn
D205 Withdrawn
D3144 Withdrawn
DSE207M Withdrawn
D3195 Withdrawn
DE210T Withdrawn
DSE211P Withdrawn
D105 Withdrawn
DE211 Withdrawn
DE503 Withdrawn
DE270-.5 Withdrawn
DE200SV Withdrawn
DSE210 Withdrawn
DS105G Withdrawn
D104P Withdrawn
DSE210T Withdrawn
DSE242 Withdrawn
DE205G Withdrawn
D347I Withdrawn
D209 Withdrawn
D207M Withdrawn
DS172 Withdrawn
DE243 Withdrawn
DE208 Withdrawn
D209TR Withdrawn
DE201H Withdrawn
DSE347SI Withdrawn
DE231 Withdrawn
DE200 Withdrawn
DSE201ST Withdrawn
DE213I Withdrawn
DSE201S Withdrawn
D203 Withdrawn
DE261A Withdrawn
DS236 Withdrawn
DS105 Withdrawn
DE261B Withdrawn
DS209TR Withdrawn
D139C Withdrawn
DS209 Withdrawn
DE105 Withdrawn
DS344Q Withdrawn
DE230N Withdrawn
D200F Withdrawn
DE104 Withdrawn
DSE231 Withdrawn
DSE200V Withdrawn
D213 Withdrawn
DS104 Withdrawn
DE199 Withdrawn
DSE270-1 Withdrawn
D215 Withdrawn
D138 Withdrawn
DSE211 Withdrawn
DSE105 Withdrawn
DSE503 Withdrawn
D208S Withdrawn
DSE138 Withdrawn
DS243 Withdrawn
D270-.7 Withdrawn
DE242N Withdrawn
DE211P Withdrawn
D347 Withdrawn
DE201S Withdrawn
D230W Withdrawn
DSE243 Withdrawn
DSE203 Withdrawn
DSE200S Withdrawn
DE212 Withdrawn
DSE208 Withdrawn
DE210 Withdrawn
DS260 Withdrawn
DSE242N Withdrawn
DE105G Withdrawn
DSE270-.5 Withdrawn
DS213S Withdrawn
DE201SA Withdrawn
DSE205G Withdrawn
DSE261B Withdrawn
DE241 Withdrawn
DE207M Withdrawn
DSE209 Withdrawn
D344Q Withdrawn
DE138 Withdrawn
D201ST Withdrawn
DE205 Withdrawn
DS215 Withdrawn
DS205G Withdrawn
DS347I Withdrawn
DS205 Withdrawn
DE347SI Withdrawn
DS139 Withdrawn
DS172A Withdrawn
DE201A Withdrawn
DSE201H Withdrawn
DS230W Withdrawn
DS270-.7 Withdrawn
DSE200SV Withdrawn
DE209 Withdrawn
DE204 Withdrawn
D151 Withdrawn
DSE199 Withdrawn
DS270-.5 Withdrawn
DSE212 Withdrawn

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
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
Plier, Orthodontic Dentaurum GmbH & Co. KG 59

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