Archwire

NiTi Thermal Euro-Form rectangle archwire lower .019" x .025" (Pack of 10 pieces)

Registry build 21.09.26
43manufacturers in China registered for this device type
457catalogue 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 Archwire
Listed by Acme-Monaco Corp., United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Manufacturer
Premarket notification Exempt
Record published 2023-03-21
Record revised 2022-08-24 (version 2)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Prescription Prescription only
UDI direct marking Exempt

Catalogue Numbers

Catalogue numbers for Archwire
Catalogue number Size Per pack Status
AMC12UNITIEU 10 In distribution
AMC1925LNITI 10 In distribution
AMC1616UMNITI10E 10 In distribution
AMC2020UNITI 10 In distribution
AMC1725UMAR 10 In distribution
AMC1825LNITIEU 10 In distribution
AMC1925UMNITI10E 10 In distribution
AMC1725LNITIEU 10 In distribution
AMC20LNITIEU 10 In distribution
AMC192536MMS In distribution
AMC1925UMNAT 10 In distribution
AMC1616UNITIDWS 10 In distribution
AMC16UNITI 10 In distribution
AMC12LMNAT 10 In distribution
AMC14LNITI 10 In distribution
AMC1616UNITIEU 10 In distribution
AMC1622UMAREU 10 In distribution
AMC192526MMS In distribution
AMC1725UNATLGST 10 In distribution
AMC14LMNITI 10 In distribution
AMC2020UNITIEU 10 In distribution
AMC192528MMS In distribution
AMC18UEUST 10 In distribution
AMC12UMAREU 10 In distribution
AMC1725RST25E 25 In distribution
73-A0L2-0018 In distribution
AMC14RCLL10E 2 In distribution
AMC16UMNAT25E In distribution
AMC18RNITI25E In distribution
73-C0U2-1622 In distribution
AMC14UMAR 10 In distribution
AMC16UMNITI10E 10 In distribution
73-A0U2-0018 In distribution
73-B0U2-1725 In distribution
AMC1725LMNITI10E 10 In distribution
73-B0U2-1925 In distribution
AMC1616LMNITI10E 10 In distribution
AMC172538MMS 10 In distribution
AMC16RCLL10E 10 In distribution
AMC1925LMRGM 10 In distribution
AMC1725UNITIEU 10 In distribution
AMC20LMAR 10 In distribution
AMC1622UMNITI10E 10 In distribution
AMC18LGRM 10 In distribution
AMC1616LNITIEU 10 In distribution
AMC175LNTW In distribution
AMC1925UNMCUN3510E 10 In distribution
AMC14UMNITI10E 10 In distribution
AMC195COAXST 10 In distribution
AMC1925RCLL10E 10 In distribution
AMC1622RCUL 10 In distribution
AMC12UMNAT 10 In distribution
77-G0L2-1925 10 In distribution
AMC1925UNITIEU 10 In distribution
73-A0U2-0016 In distribution
AMC18UNITIEU 10 In distribution
AMC1622LNATLGNT 10 In distribution
AMC12UNITI 10 In distribution
AMC1825UNITI In distribution
AMC14RCUL10E 2 In distribution
AMC16LGRM 10 In distribution
AMC1616LNATLGNT 10 In distribution
AMC12LMNITI10E 10 In distribution
AMC1616LNAT 10 In distribution
AMC18UNATLGST 10 In distribution
AMC1622RCUNITI35 10 In distribution
AMC18RCUNITI35 10 In distribution
73-A0L2-1825 In distribution
AMC14RNITI25E In distribution
73-A0U2-1725 In distribution
73-C0L2-1725 In distribution
AMC1818UNAT 10 In distribution
AMC1725UMNAT 10 In distribution
AMC1616UMNAT25E In distribution
AMC16RCUL10E 10 In distribution
AMC1622UMNAT 10 In distribution
AMC14LMAR 10 In distribution
AMC12LMNITI 10 In distribution
AMC16UMNAT25E In distribution
AMC1425UNITI 10 In distribution
AMC18LEUST 10 In distribution
AMC12UMAR 10 In distribution
AMC1925UNATLGST 10 In distribution
AMC14UMAREU 10 In distribution
AMC14UGRMR In distribution
AMC2125UEUST 10 In distribution
AMC1616LNATLGST 10 In distribution
AMC20UMNITI10E 10 In distribution
AMC1725LMAREU 10 In distribution
AMC1725UGRM 10 In distribution
AMC162230MMS 10 In distribution
D972AMC20UMNAT25EU6 In distribution
AMC14LNITIEU 10 In distribution
AMC1622LMAR 10 In distribution
AMC16LMNITI10E 10 In distribution
AMC20UMAREU 10 In distribution
AMC1818LMAREU 10 In distribution
AMC14UNITIDWS 10 In distribution
AMC1616UNBTNE 10 In distribution
AMC1622LNATLGST 10 In distribution
AMC14LNMCUN3510E 10 In distribution
AMC1925UMAR 10 In distribution
77-G0L2-0018 10 In distribution
73-C0U2-1825 In distribution
AMC1818LNITIEU 10 In distribution
AMC1925LNITI In distribution
AMC1616UMNITI 10 In distribution
AMC16RCUNITI35 10 In distribution
AMC14UNITI 10 In distribution
AMC1425RCUNITI35 10 In distribution
AMC1616RCLL10E 2 In distribution
AMC1622UMNITI 10 In distribution
AMC12LNITIDWS 10 In distribution
AMC1622LNAT 10 In distribution
AMC18UNATLGNT 10 In distribution
AMC14LNITIDWS 10 In distribution
AMC1925NATLGNT 10 In distribution
73-A0U2-1825 In distribution
AMC1616LEUST 10 In distribution
AMC16UMNAT 10 In distribution
AMC20LNATLGST 10 In distribution
AMC1925LNMCUN3510E 10 In distribution
73-A0L2-1622 In distribution
AMC16UGRM 10 In distribution
AMC12LMAREU 10 In distribution
AMC18UMNAT25E In distribution
AMC162228MMS In distribution
AMC2125UNAT 10 In distribution
AMC20LMNAT25E In distribution
AMC1622RST25E 25 In distribution
AMC2020LNITI 10 In distribution
73-C0L2-2125 In distribution
AMC2125UMAR 10 In distribution
AMC12LNITIEU 10 In distribution
AMC1725UMNITI 10 In distribution
AMC2125LNITIDWS 10 In distribution
AMC1825UNITI 10 In distribution
AMC16LNATLGNT 10 In distribution
AMC1925LNITIDWS 10 In distribution
AMC1616LNBTNE 10 In distribution
AMC20UEUST 10 In distribution
AMC16LNITI 10 In distribution
AMC20UMNAT 10 In distribution
AMC1825RCUL10E 10 In distribution
AMC18UMNAT 10 In distribution
AMC16RCLL In distribution
AMC14UNATLGNT 10 In distribution
AMC1616RST25E 25 In distribution
AMC1622UEUST 10 In distribution
AMC16LEUST 10 In distribution
AMC1825UNAT 10 In distribution
AMC1725LNBTNE 10 In distribution
AMC2125LNITI 10 In distribution
AMC1622UNITIDWS 10 In distribution
AMC192538MMS In distribution
AMC20UNAT 10 In distribution
AMC1925UEUST 10 In distribution
AMC14LNITI In distribution
AMC1725LNITIDWS 10 In distribution
AMC1825LNITI In distribution
AMC14LMNAT25E In distribution
AMC192524MMS In distribution
AMC1725UNITI In distribution
AMC18LNATLGST 10 In distribution
AMC12LNITI In distribution
AMC16UNBTNE 10 In distribution
AMC192534MMS In distribution
AMC1622UMNAT25E In distribution
AMC18LNAT 10 In distribution
AMC1622LMNITI10E 10 In distribution
AMC1616UMAR 10 In distribution
AMC14LNATLGST 10 In distribution
AMC18UMNITI10E 10 In distribution
AMC2125UMNAT25EKF1 In distribution
AMC1725UNITI 10 In distribution
AMC16UNMCUN3510E 10 In distribution
AMC20UNATLGNT 10 In distribution
77-G0U2-0016 10 In distribution
AMC16LNITI In distribution
73-A0U2-1925 In distribution
AMC1725UNMCUN3510E 10 In distribution
AMC16RCUL In distribution
AMC172532MMS 10 In distribution
77-G0U2-1925 10 In distribution
AMC1925UBRNA 10 In distribution
AMC16UNATLGST 10 In distribution
AMC1616UNATLGST 10 In distribution
AMC14UGRST 10 In distribution
AMC1616LMNAT 10 In distribution
AMC16UMNITI 10 In distribution
AMC1725RCLL In distribution
AMC1818UNITI 10 In distribution
AMC1825UMNITI10E 10 In distribution
AMC14RCUL In distribution
AMC1825LNMCUN3510E 10 In distribution
AMC1725UNATLGNT 10 In distribution
73-A0U2-1622 In distribution
AMC1925UNATLGNT 10 In distribution
AMC18UNITI In distribution
73-B0L2-1725 In distribution
AMC1925RCUL10E 10 In distribution
AMC1925RCLL In distribution
AMC20LEUST 10 In distribution
73-C0U2-1725 In distribution
AMC1622UNMCUN3510E 10 In distribution
AMC1616UMNAT 10 In distribution
AMC2020LMAREU 10 In distribution
AMC18UNMCUN3510E 10 In distribution
AMC1725UNITIDWS 10 In distribution
AMC1818LNITI 10 In distribution
AMC18UGRST 10 In distribution
AMC20LMAREU 10 In distribution
AMC1622RNITI25E In distribution
AMC14RCUNITI35 10 In distribution
AMC1725LMAR 10 In distribution
AMC1725RCUL10E 10 In distribution
AMC1616LMNITI 10 In distribution
AMC2125UMAREU 10 In distribution
AMC20LMNAT 10 In distribution
AMC1925LNATLGST 10 In distribution
AMC1925UNBTNE 10 In distribution
AMC1622LNITI 10 In distribution
AMC1622LGRM 10 In distribution
AMC14LMAREU 10 In distribution
AMC1725LMNITI 10 In distribution
AMC1825LMAR 10 In distribution
AMC1622LNITIDWS 10 In distribution
AMC1616LGRST 10 In distribution
AMC1925LMNITI 10 In distribution
AMC18UGRM 10 In distribution
AMC1725LNITI 10 In distribution
AMC1725RCUL In distribution
AMC16LNITIEU 10 In distribution
AMC10UNITI In distribution
AMC18RCUL10E 10 In distribution
AMC20LNITI 10 In distribution
AMC14LNATLGNT 10 In distribution
AMC1622UNITI 10 In distribution
AMC1616LMNAT25E In distribution
AMC1622RCLL In distribution
AMC1725UMAREU 10 In distribution
AMC18UMNITI 10 In distribution
AMC1925UNAT 10 In distribution
AMC18LNATLGNT 10 In distribution
AMC16UMAR 10 In distribution
AMC1925RST 10 In distribution
AMC1925UNITI 10 In distribution
AMC1825UNMCUN3510E 10 In distribution
AMC195UNCOAXST 10 In distribution
AMC1725LNATLGNT 10 In distribution

Showing 250 of 300 catalogue numbers.

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