Phoenix Nickel Titanium

NT Variable Force 12MM Closed Coil SPG W Eyelet MEDIUM.011X.030 PK10

Registry build 21.09.26
22manufacturers in China registered for this device type
21catalogue 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 Phoenix Nickel Titanium
Listed by Phoenix Orthodontics Inc, United States
FDA product code ECO
Device type Spring, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2020-08-17
Record revised 2024-09-02 (version 3)

Specifications

Specifications
MRI safety MR Conditional
Single use Yes
Prescription Prescription only
Label carries lot or batch number, expiry date, manufacturing date
Sizes Outer diameter 0.01 to 0.018 in; lumen/inner diameter 0.03 to 0.045 in; length 7 to 15 in
Distribution end date 2024-09-02

Catalogue Numbers

Catalogue numbers for Phoenix Nickel Titanium
Catalogue number Size Per pack Status
N-OCS-1030 Lumen/Inner Diameter 0.030 in Withdrawn
N-OC-1030 Length 7 in 10 Withdrawn
N-NSL Outer Diameter 0.018 in 25 Withdrawn
N-CCV910-1130 10 Withdrawn
NTSW-1045- Outer Diameter 0.010 in 3 Withdrawn
N-CCE10-12M 10 Withdrawn
N-OC-1230 Outer Diameter 0.012 in 10 Withdrawn
N-CCV910-1230 10 Withdrawn
N-CCE10-9M 10 Withdrawn
N-OCS-1230 Outer Diameter 0.012 in Withdrawn
N-OC-1045 Lumen/Inner Diameter 0.045 in 10 Withdrawn
N-CC10-9H 10 Withdrawn
N-CC10-12H 10 Withdrawn
N-CC10-9M 10 Withdrawn
N-OCS-1045 Length 15 in Withdrawn
N-CCE10-9H 10 Withdrawn
N-NSS Outer Diameter 0.018 in 25 Withdrawn
N-CCV1210-1230 10 Withdrawn
N-CCV1210-1130 10 Withdrawn
N-CCE10-12H 10 Withdrawn
N-CC10-12M 10 Withdrawn

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
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