Stainless Steel Archwires

.016 X .022 Lower Bright Stainless Steel Oval Arch Form III Archwires

Registry build 21.09.26
43manufacturers in China registered for this device type
56catalogue 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 Stainless Steel Archwires
Listed by Ortho Organizers, Inc., United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Specification developer, Repacker / relabeller, Manufacturer
Premarket notification Exempt
Record published 2020-07-13
Record revised 2025-12-30 (version 5)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
Label carries lot or batch number, manufacturing date
Distribution end date 2025-02-25
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Stainless Steel Archwires
Catalogue number Size Status
101-413 In distribution
101-405 In distribution
101-412 In distribution
101-409 In distribution
101-415 In distribution
101-402 In distribution
101-418 In distribution
101-421 In distribution
101-406 In distribution
101-414 In distribution
101-410 In distribution
101-404 In distribution
101-419 In distribution
101-408 In distribution
101-403 In distribution
101-420 In distribution
101-407 In distribution
101-411 In distribution
101-417 Withdrawn
101-416 Withdrawn
100-155B Withdrawn
100-145B Withdrawn
100-157 Withdrawn
100-156B Withdrawn
100-158B Withdrawn
100-141B Withdrawn
100-051 Withdrawn
100-155 Withdrawn
100-148B Withdrawn
100-153B Withdrawn
100-146B Withdrawn
100-151B Withdrawn
100-156 Withdrawn
100-143B Withdrawn
100-154B Withdrawn
100-153 Withdrawn
100-161B Withdrawn
100-152B Withdrawn
100-159 Withdrawn
100-140B Withdrawn
100-150B Withdrawn
100-154 Withdrawn
100-158 Withdrawn
100-047 Withdrawn
100-144B Withdrawn
100-159B Withdrawn
100-147B Withdrawn
100-160B Withdrawn
100-049 Withdrawn
100-149B Withdrawn
100-052 Withdrawn
100-046 Withdrawn
100-142B Withdrawn
100-157B Withdrawn
100-161 Withdrawn
100-160 Withdrawn

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