ART Spring

Wire Anterior Root Torquing (ART) Spring U/L Assortment Sizes KIT

Registry build 21.09.26
22manufacturers in China registered for this device type
7catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (8), Guangdong (4), Jiangsu (3). 3 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code ECO
Manufacturer City Province Registered as Device types
Shenzhen Denco Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 52
Improve Co., Limited Lantau Island Hong Kong Contract manufacturer 16
Sino Ortho Limited Hangzhou Zhejiang Contract manufacturer 14
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Shenzhen Rogin Medical Co., Ltd. Shenzhen Guangdong Contract manufacturer 51
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
Zhejiang Protect Medical Equipment Co., Ltd. Anji Zhejiang Manufacturer 16
Guangzhou Cheer-U Material Technology Co., Ltd. Guangzhou Guangdong Manufacturer 15
Innovative Material & Devices, Inc. Wuxi Jiangsu Contract manufacturer 13

Showing 12 of 22. All 22 manufacturers in China registered for Spring, Orthodontic

Record

Regulatory record for ART Spring
Listed by American Orthodontics, United States
FDA product code ECO
Device type Spring, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2020-05-12
Record revised 2024-12-31 (version 3)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date

Catalogue Numbers

Catalogue numbers for ART Spring
Catalogue number Size Status
855-032525 In distribution
855-032526 In distribution
855-032524 In distribution
855-032523 In distribution
855-032528 In distribution
855-032522 In distribution
855-032527 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
RMO RMO 57
3M™ Unitek™ 3M Unitek 51
Aditek Aditek DO Brasil S/A 47
OSE Orthodontic Supply & Equipment Co., Inc. 40
3M™ Forsus™ 3M Unitek 35
Masel Ortho Organizers, Inc. 33
The Orthodontic Store Young Innovations Inc. 31
Advance Dental Products THE Atlanta Dental Supply Company 30
Mico One Orthodontic Spring ZE Fang Technology Co., Ltd. 29
NiTi Spring American Orthodontics 26
Orthodontic Spring Dentos, Incorporated 25
Phoenix Nickel Titanium Phoenix Orthodontics Inc 21

Showing 12 of 168. All products under Spring, 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