Beta Titanium Wire

Wire B-TI Lower 017X025 Long Modified IND 10/PK

Registry build 21.09.26
43manufacturers in China registered for this device type
302catalogue 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 Beta Titanium Wire
Listed by American Orthodontics, United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Contract manufacturer, Repacker / relabeller, Complaint-file establishment, Manufacturer
Premarket notification Exempt
Record published 2018-07-12
Record revised 2025-07-25 (version 8)

Specifications

Specifications
MRI safety MR Unsafe
Single use Yes
Prescription Prescription only
Supplied as a kit Yes
Label carries lot or batch number, manufacturing date
Storage Storage environment humidity 0 to 60 % RH; Storage environment temperature up to 38 °C
Distribution end date 2025-07-24

Catalogue Numbers

Catalogue numbers for Beta Titanium Wire
Catalogue number Size Status
845-VX-1825W In distribution
857-697SP In distribution
857-658 In distribution
857-674A In distribution
845-ALGU-1825W In distribution
857-670SPW In distribution
845-VM-2020W In distribution
845-VX-1625 In distribution
845-VX-1625W In distribution
857-671W In distribution
857-680SP In distribution
845-VS-1925 In distribution
845-VM-1625W In distribution
845-AMDU-2020 In distribution
857-690SP In distribution
845-VM-1825W In distribution
857-683W In distribution
845-ALGL-1825 In distribution
845-ALGU-16W In distribution
845-VX-18W In distribution
857-685 In distribution
845-VM-1825 In distribution
845-VX-2020W In distribution
845-AMDL-1818W In distribution
857-674W In distribution
845-AMDL-2020 In distribution
857-682I In distribution
857-658I In distribution
857-685IW In distribution
845-ALGU-1622W In distribution
857-687IW In distribution
857-676IW In distribution
845-AMDL-1622 In distribution
857-671I In distribution
845-3L-2020W In distribution
845-3L-2020 In distribution
857-691SP In distribution
857-684IW In distribution
857-674AW In distribution
845-VX-1925 In distribution
845-VX-1622 In distribution
845-VS-2020 In distribution
845-VM-1725W In distribution
857-646 In distribution
857-646W In distribution
857-681W In distribution
845-ALGL-1622 In distribution
857-681I In distribution
845-AMDU-2125W In distribution
845-ALGU-1825 In distribution
845-AMDU-1725W In distribution
845-ALGL-2125W In distribution
857-681IW In distribution
857-692 In distribution
857-672I In distribution
845-VX-16 In distribution
857-670SP In distribution
857-683ISP In distribution
857-684 In distribution
857-686 In distribution
845-AMDU-1825 In distribution
845-AMDL-2020W In distribution
845-ALGU-2020W In distribution
857-658W In distribution
845-ALGL-1825W In distribution
857-677IW In distribution
845-ALGL-1622W In distribution
857-681 In distribution
857-677W In distribution
845-ALGL-18 In distribution
857-656I In distribution
857-656 In distribution
845-AMDL-1725 In distribution
857-700SP In distribution
845-VM-1818 In distribution
845-ALGL-1725 In distribution
845-VM-1925W In distribution
845-ALGU-1725 In distribution
845-3U-2020 In distribution
857-696 In distribution
857-674IW In distribution
857-672AW In distribution
857-687I In distribution
845-VM-1818W In distribution
845-VM-1725 In distribution
845-ALGU-18 In distribution
845-VM-1622 In distribution
845-VX-1825 In distribution
845-AMDU-1622W In distribution
845-ALGU-2125 In distribution
845-ALGU-18W In distribution
845-ALGU-1925 In distribution
857-680SPW In distribution
845-VX-1818 In distribution
845-AMDL-1925W In distribution
845-VS-1725W In distribution
857-687W In distribution
857-684I In distribution
845-ALGL-2020 In distribution
857-675IW In distribution
857-673ISP In distribution
845-VM-18W In distribution
845-VX-16W In distribution
857-677I In distribution
845-VM-18 In distribution
845-ALGU-1818W In distribution
845-AMDL-1825 In distribution
845-VS-1725 In distribution
845-ALGU-1622 In distribution
857-648IW In distribution
857-671 In distribution
857-675W In distribution
857-646I In distribution
857-656IW In distribution
845-VM-1925 In distribution
857-687 In distribution
845-VM-1625 In distribution
857-682IW In distribution
845-ALGU-1925W In distribution
845-VX-1925W In distribution
857-685W In distribution
857-683ISPW In distribution
845-VM-16 In distribution
845-ALGL-1925 In distribution
857-673ISPW In distribution
845-AMDL-1725W In distribution
845-ALGL-1725W In distribution
857-685I In distribution
845-VS-1925W In distribution
845-ALGL-18W In distribution
845-VX-1725 In distribution
857-674I In distribution
857-648W In distribution
857-698SP In distribution
845-AMDL-1925 In distribution
857-656W In distribution
845-AMDU-1825W In distribution
857-676 In distribution
845-VM-2020 In distribution
857-684AW In distribution
845-VS-1625W In distribution
845-VX-18 In distribution
857-677 In distribution
857-682A In distribution
845-VS-1818 In distribution
857-672 In distribution
845-VX-1818W In distribution
845-ALGL-1818 In distribution
845-AMDU-1818W In distribution
845-AMDU-1925W In distribution
857-658IW In distribution
845-3U-2020W In distribution
845-VX-1725W In distribution
857-683 In distribution
845-VS-1622W In distribution
857-671IW In distribution
857-686IW In distribution
857-675I In distribution
845-ALGU-1818 In distribution
857-648 In distribution
857-648I In distribution
845-VM-16W In distribution
845-AMDU-1622 In distribution
857-699SP In distribution
845-ALGL-1925W In distribution
845-VM-1622W In distribution
857-672IW In distribution
857-672A In distribution
857-674 In distribution
845-AMDL-1825W In distribution
857-673W In distribution
845-ALGL-1818W In distribution
845-ALGU-1725W In distribution
857-682W In distribution
845-AMDU-1725 In distribution
857-701SP In distribution
845-VS-1625 In distribution
845-AMDL-2125W In distribution
845-VX-2020 In distribution
857-675 In distribution
845-AMDU-1925 In distribution
845-VS-1622 In distribution
857-684W In distribution
845-VX-1622W In distribution
857-646IW In distribution
845-AMDU-2020W In distribution
857-684A In distribution
857-673 In distribution
845-ALGU-2125W In distribution
845-ALGU-2020 In distribution
857-682AW In distribution
845-AMDL-1622W In distribution
857-682 In distribution
845-VS-1825W In distribution
857-672W In distribution
845-VX-16W Withdrawn
845-ALGL-16W Withdrawn
845-ALGU-18W Withdrawn
845-AMDU-16W Withdrawn
845-VS-1925W Withdrawn
845-ALGU-2020W Withdrawn
845-ALGU-16W Withdrawn
845-AMDU-16W Withdrawn
857-686I Withdrawn
845-VM-16W Withdrawn
845-ALGU-16 Withdrawn
845-ALGL-1825W Withdrawn
845-ALGL-1625W Withdrawn
845-VX-1818W Withdrawn
845-ALGU-1818W Withdrawn
845-AMDL-2125W Withdrawn
845-VX-1625W Withdrawn
845-VS-1622W Withdrawn
857-676I Withdrawn
845-ALGL-2020W Withdrawn
845-AMDU-18 Withdrawn
845-VS-1818W Withdrawn
845-ALGL-16 Withdrawn
845-ALGU-2125W Withdrawn
857-672M Withdrawn
845-VS-18 Withdrawn
845-ALGL-16W Withdrawn
845-VS-18W Withdrawn
845-ALGU-1625W Withdrawn
845-AMDL-1725W Withdrawn
845-ALGL-2125 Withdrawn
845-VM-1725W Withdrawn
845-AMDL-1625W Withdrawn
845-VM-1825W Withdrawn
845-VS-1725W Withdrawn
845-ALGL-1925W Withdrawn
845-ALGU-1625 Withdrawn
845-VS-2020W Withdrawn
857-682M Withdrawn
845-AMDL-1818 Withdrawn
845-VS-1825 Withdrawn
845-AMDU-1625W Withdrawn
845-AMDL-1625 Withdrawn
845-VS-1825W Withdrawn
845-ALGU-1725W Withdrawn
845-VX-1825W Withdrawn
845-AMDU-1625W Withdrawn
845-AMDU-1818W Withdrawn
857-682MW Withdrawn
845-AMDL-1818W Withdrawn
845-AMDU-1825W Withdrawn
845-VX-1725W Withdrawn
845-VS-18W Withdrawn
845-ALGU-1625W Withdrawn
845-VM-1925W Withdrawn

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