Slim Tube

Tube Slim Flangeless NON-Conv Single MAX Left/Mand Right Molar T-10 R=0.018

Registry build 21.09.26
34manufacturers in China registered for this device type
46catalogue 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 Slim Tube
Listed by American Orthodontics, United States
FDA product code DZD
Device type Tube, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2017-11-17
Record revised 2025-05-16 (version 9)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Over the counter Yes
Label carries lot or batch number, manufacturing date
Distribution end date 2025-07-24

Catalogue Numbers

Catalogue numbers for Slim Tube
Catalogue number Size Status
956-4000C In distribution
956-4020C In distribution
952-4021C In distribution
952-4031C In distribution
958-4011C In distribution
955-4002C In distribution
953-4021C In distribution
953-4002C In distribution
951-4023C In distribution
951-4000C In distribution
953-4001C In distribution
958-4021C In distribution
957-4030C In distribution
954-4020C In distribution
952-4022C In distribution
951-4030C In distribution
954-4000C In distribution
958-4001C In distribution
954-4003C In distribution
956-4023C In distribution
958-4031C In distribution
955-4021C In distribution
954-4023C In distribution
957-4000C In distribution
953-4022C In distribution
952-4001C In distribution
957-4010C In distribution
951-4010C In distribution
955-4001C In distribution
955-4022C In distribution
957-4020C In distribution
956-4003C In distribution
951-4020C In distribution
952-4011C In distribution
004-4001CF Withdrawn
004-4022CF Withdrawn
004-4023CF Withdrawn
004-4002CF Withdrawn
004-4000CF Withdrawn
004-4003CF Withdrawn
955-4022CAU Withdrawn
951-4023C Withdrawn
004-4020CF Withdrawn
952-4022C Withdrawn
004-4021CF Withdrawn
956-4023CAU Withdrawn

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