Heat Activated Nitinol Archwire

.016 X.016 Upper Heat Activated Nitinol With Dimple Right Form (10)

Registry build 21.09.26
43manufacturers in China registered for this device type
30catalogue numbers in this listing

Who Else Makes It

Concentrated in Zhejiang (15), Guangdong (9), Jiangsu (6). 7 of them are registered as contract manufacturers, able to build to a buyer’s own specification.

Chinese manufacturers registered for FDA product code DZC
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
Zhejiang Eksen Medical Technology Co., Ltd. Huzhou Zhejiang Contract manufacturer 9
Yancheng Denrum Medical Apparatus Co., Ltd. Yancheng Jiangsu Contract manufacturer 5
Heilongjiang Rainbow Technology Co., Ltd. Jiamusi Heilongjiang Contract manufacturer 2
Debo Medical Technology (Shijiazhuang) Co., Ltd. Shijiazhuang Hebei Contract manufacturer 117
Hubei Guarddent Medical Technology Co., Ltd. Wuhan Hubei Manufacturer 60
Shanghai Kangqiao Dental Instruments Factory Shanghai Shanghai Manufacturer 54
Zhejiang Yamei Medical Equipment Technology Co., Ltd. Yang Jiao Lang Zin’An Town Zhejiang Manufacturer 39
Hangzhou Wise Medical Device Co., Ltd. Hangzhou Zhejiang Contract manufacturer 25

Showing 12 of 43. All 43 manufacturers in China registered for Wire, Orthodontic

Record

Regulatory record for heat activated nitinol archwire
Listed by Ortho Arch Company Inc, United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2022-01-13

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for heat activated nitinol archwire
Catalogue number Size Status
226-508 In distribution
226-507 In distribution
226-510 In distribution
226-511 In distribution
226-525 In distribution
226-515 In distribution
226-514 In distribution
226-527 In distribution
226-522 In distribution
226-520 In distribution
226-526 In distribution
226-513 In distribution
226-518 In distribution
226-524 In distribution
226-503 In distribution
226-504 In distribution
226-529 In distribution
226-517 In distribution
226-501 In distribution
226-509 In distribution
226-521 In distribution
226-528 In distribution
226-523 In distribution
226-502 In distribution
226-505 In distribution
226-516 In distribution
226-500 In distribution
226-512 In distribution
226-519 In distribution
226-506 In distribution

Same Product Code

Other products under the same FDA product code
Product Sold by Catalogue numbers
Wire, Orthodontic G & H Wire Company 2,746
Europa G & H Wire Company 2,409
Pg Supply PG Supply, Inc. 1,990
Trueform G & H Wire Company 1,984
G4 Nickel Titanium G & H Wire Company 957
Tanzo American Orthodontics 906
Aditek Aditek DO Brasil S/A 879
G4 Europa Nickel Titanium G & H Wire Company 819
3M™ Unitek™ 3M Unitek 729
Orthodontic wire Dentos, Incorporated 711
Orthoquest Young Innovations Inc. 698
NT3 American Orthodontics 694

Showing 12 of 679. All products under Wire, 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