Plier, Orthodontic

The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire or to cut out or make dents in several places on the resin…

Registry build 21.09.26

The intended medical indication is to use to hold or to fix or to remove small objects or to bend or to cut metal strips or wire or to cut out or make dents in several places on the resin orthodontic appliance.

28manufacturers in China registered for this device type
67catalogue 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 Plier, Orthodontic
Listed by YDM Corporation, Japan
FDA product code JEX
Device type Plier, Orthodontic
Device class Class 1
Regulation 21 CFR 872.4565
Establishment Manufacturer
Premarket notification Exempt
Record published 2022-11-15

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Sterilisation Moist Heat or Steam Sterilization
Label carries lot or batch number, manufacturing date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Plier, Orthodontic
Catalogue number Size Status
27428 In distribution
27610 In distribution
27452 In distribution
27934 In distribution
27466 In distribution
27450 In distribution
27415 In distribution
27412 In distribution
27602 In distribution
27429 In distribution
27414 In distribution
27413 In distribution
27416 In distribution
27410 In distribution
27454 In distribution
27420 In distribution
27419 In distribution
27462 In distribution
27451 In distribution
22508 In distribution
27606 In distribution
22001 In distribution
27463 In distribution
22551 In distribution
27455 In distribution
27604 In distribution
27605 In distribution
27460 In distribution
27449 In distribution
27418 In distribution
27603 In distribution
27607 In distribution
27444 In distribution
27443 In distribution
27464 In distribution
27422 In distribution
27458 In distribution
22514 In distribution
27465 In distribution
27456 In distribution
27448 In distribution
27445 In distribution
27459 In distribution
22510 In distribution
27426 In distribution
27417 In distribution
27453 In distribution
27423 In distribution
22506 In distribution
22511 In distribution
27421 In distribution
22509 In distribution
22507 In distribution
27457 In distribution
27601 In distribution
27440 In distribution
27424 In distribution
27427 In distribution
27615 In distribution
22513 In distribution
27442 In distribution
27441 In distribution
27425 In distribution
27461 In distribution
27411 In distribution
27447 In distribution
27446 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
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