ORJ

Orthodontic Niti Archwires for Teeth Correction

Registry build 21.09.26
27manufacturers in China registered for this device type
18catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (13), Jiangsu (5), Guangdong (3). One is registered as a contract manufacturer, able to build to a specification.

Chinese manufacturers registered for FDA product code ECN
Manufacturer City Province Registered as Device types
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Shanghai Medical Instruments (Group) Ltd. Corp. Shanghai Shanghai Contract manufacturer 235
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
Huanghua Promisee Dental Co., Ltd. Huanghua Hebei Manufacturer 54
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Henan Baistra Medical Devices Limited Zhengzhou Henan Manufacturer 34
Huizhou Videya Technology Co., Ltd. Huizhou Guangdong Manufacturer 18
Changsha Nice Medical Instrument Limited Company Changsha Hunan Manufacturer 17
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17
Zhejiang Protect Medical Equipment Co., Ltd. Anji Zhejiang Manufacturer 16
Guangzhou Cheer-U Material Technology Co., Ltd. Guangzhou Guangdong Manufacturer 15

Showing 12 of 27. All 27 manufacturers in China registered for Clamp, Wire, Orthodontic

Record

Regulatory record for ORJ
Listed by Fortune Worldwide LLC
FDA product code ECN
Device type Clamp, Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2022-11-04
Record revised 2023-06-12 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes

Catalogue Numbers

Catalogue numbers for ORJ
Catalogue number Size Status
W121-1825L In distribution
W121-1825U In distribution
W121-14U In distribution
W121-12U In distribution
W121-16L In distribution
W411-12U In distribution
W121-20U In distribution
W121-16U In distribution
W121-1725L In distribution
W121-1622L In distribution
W121-1725U In distribution
W121-14L In distribution
W121-12L In distribution
W121-18U In distribution
W121-18L In distribution
W121-1622U In distribution
W121-1925U In distribution
W121-1925L In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
3M™ Unitek™ 3M Unitek 58
Lingual Sheaths American Orthodontics 36
Crimpable Stop American Orthodontics 29
Arch Hook American Orthodontics 26
JMU JMU Dental, Inc 25
Clamp, Wire, Orthodontic Dentaurum GmbH & Co. KG 24
OSE Orthodontic Supply & Equipment Co., Inc. 22
Buttons American Orthodontics 22
Morelli Dental Morelli Ltda. 21
Arch Lock American Orthodontics 19
The Orthodontic Store Young Innovations Inc. 17
DTC Hangzhou DTC Medical Apparatus Co., Ltd. 16

Showing 12 of 405. All products under Clamp, Wire, 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