Aditek

Niti Retraction Closed Coil Spring 012X030 15 mm w/04

Registry build 21.09.26
22manufacturers in China registered for this device type
47catalogue 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 Aditek
Listed by Aditek DO Brasil S/A
FDA product code ECO
Device type Spring, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Premarket notification Exempt
Record published 2023-09-11
Record revised 2024-05-16 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number, expiry date, manufacturing date, serial number

Catalogue Numbers

Catalogue numbers for Aditek
Catalogue number Size Status
WI1-07.11.4305 In distribution
07.11.3703 In distribution
07.11.4105 In distribution
07.11.3303 In distribution
07.11.3803 In distribution
07.10.2602 In distribution
WI1-07.11.3205 In distribution
07.11.4303 In distribution
07.10.3002 In distribution
WI1-07.11.4005 In distribution
WI1-07.11.3505 In distribution
07.11.3705 In distribution
07.11.4005 In distribution
07.11.3503 In distribution
WI1-07.10.2602 In distribution
07.11.3903 In distribution
07.11.3805 In distribution
07.10.2702 In distribution
07.11.4305 In distribution
07.11.4103 In distribution
07.09.2907 In distribution
07.11.3203 In distribution
07.11.3603 In distribution
WI1-07.11.3305 In distribution
WI1-07.10.3002 In distribution
WI1-07.09.2907 In distribution
07.11.3605 In distribution
07.11.3305 In distribution
WI1-07.10.2702 In distribution
WI1-07.11.4205 In distribution
07.10.2802 In distribution
07.11.4203 In distribution
WI1-07.10.2802 In distribution
WI1-07.11.3805 In distribution
07.11.3405 In distribution
07.09.3107 In distribution
07.11.4003 In distribution
07.11.3905 In distribution
WI1-07.11.3905 In distribution
07.11.3205 In distribution
WI1-07.11.4105 In distribution
WI1-07.11.3605 In distribution
07.11.4205 In distribution
WI1-07.11.3705 In distribution
07.11.3505 In distribution
WI1-07.09.3107 In distribution
07.11.3403 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
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
Morelli Dental Morelli Ltda. 20

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