ORJ

Orthodontic Metal Elliptical Button for Teeth Correction

Registry build 21.09.26
34manufacturers in China registered for this device type
32catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (20), Jiangsu (4), Guangdong (4). 5 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZD
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
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Hangzhou Westlake Biomaterial Co., Ltd. Hangzhou Zhejiang Contract manufacturer 13
Hangzhou Xingchen 3B Dental Instrument & Materials Co., Ltd. Hangzhou Zhejiang Contract manufacturer 7
Wuxi Lyusmile IMP AND EXP Co., Ltd. Wuxi Jiangsu Private-label distributor 66
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
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
Orthguide Medical Technology (Jiangsu) Co., Ltd. Wuxi Jiangsu Contract manufacturer 17

Showing 12 of 34. All 34 manufacturers in China registered for Tube, Orthodontic

Record

Regulatory record for ORJ
Listed by Fortune Worldwide LLC
FDA product code DZD
Device type Tube, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2023-01-23

Specifications

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

Catalogue Numbers

Catalogue numbers for ORJ
Catalogue number Size Status
F201-02 In distribution
J722-5145 In distribution
J722-5125 In distribution
J632-5115 In distribution
PP20225 In distribution
AFA215 In distribution
F201-04L In distribution
F301-02 In distribution
AFA255 In distribution
F202-02 In distribution
F201-03 In distribution
J622-5135 In distribution
J721-5135 In distribution
J622-5125 In distribution
F307-01 In distribution
J621-5115 In distribution
J621-5145 In distribution
J622-5145 In distribution
F301-01 In distribution
J721-5115 In distribution
J632-5145 In distribution
J622-5115 In distribution
J621-5125 In distribution
J721-5145 In distribution
F201-04R In distribution
J621-5135 In distribution
J722-5135 In distribution
GP20225 In distribution
J632-5135 In distribution
J722-5115 In distribution
J632-5125 In distribution
J721-5125 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Tube, Orthodontic Forestadent Bernhard Förster GmbH 2,336
Generic Buccal Tubes American Orthodontics 799
Tube, Orthodontic G & H Wire Company 758
Leone SPA Leone SPA 722
RMO RMO 697
Tube, Orthodontic Dentaurum GmbH & Co. KG 602
LP Low Profile American Orthodontics 506
3M™ Unitek™ Victory Series™ 3M Unitek 434
Buccal Tubes American Orthodontics 356
Peerless Buccal Tube Ormco Corporation 331
Empower Tube American Orthodontics 296
Mini Master Series American Orthodontics 289

Showing 12 of 333. All products under Tube, 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