Orthometric Tubes Advanced Series

Welding Tube Advanced Series Roth 0,022"-SINGLE 1° MOL Upper Right (16/17)

Registry build 21.09.26
34manufacturers in China registered for this device type
47catalogue 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 Orthometric Tubes Advanced Series
Listed by Orthometric – Industria E Comercio DE Produtos Medicos E Odontologicos Ltda
FDA product code DZD
Device type Tube, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2022-09-27

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, expiry date
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Orthometric Tubes Advanced Series
Catalogue number Size Status
20.02.0016 In distribution
20.02.0046 In distribution
21.02.1146 In distribution
20.02.0246 In distribution
21.02.1037 In distribution
20.02.0146 In distribution
20.12.0016 In distribution
21.32.1026 In distribution
20.02.0446 In distribution
21.22.1116 In distribution
20.02.0126 In distribution
20.12.0026 In distribution
20.12.1436 In distribution
21.02.1027 In distribution
20.12.1426 In distribution
20.02.0316 In distribution
20.02.0436 In distribution
21.22.1027 In distribution
20.02.0136 In distribution
20.12.1416 In distribution
20.02.0216 In distribution
20.02.0236 In distribution
20.02.0326 In distribution
21.22.1016 In distribution
20.12.1446 In distribution
20.12.0046 In distribution
20.02.0416 In distribution
20.02.0426 In distribution
21.32.1016 In distribution
20.02.0026 In distribution
20.02.0037 In distribution
20.12.0036 In distribution
21.12.1147 In distribution
21.32.1036 In distribution
21.12.1146 In distribution
21.02.1017 In distribution
20.02.0116 In distribution
20.02.0036 In distribution
21.32.1046 In distribution
21.02.1047 In distribution
20.02.0226 In distribution
20.02.0017 In distribution
21.22.1017 In distribution
21.02.1147 In distribution
20.02.0047 In distribution
21.22.1117 In distribution
20.02.0027 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