Therma-Ti Lite

Wire Therma TI Lite Form III Lower 0175X0175 W/Dimple IND 10/PK

Registry build 21.09.26
43manufacturers in China registered for this device type
229catalogue 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 Therma-Ti Lite
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
Record published 2017-10-20
Record revised 2024-12-31 (version 6)

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
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 2023-06-06

Catalogue Numbers

Catalogue numbers for Therma-Ti Lite
Catalogue number Size Status
857-962IW In distribution
857-957W In distribution
857-926W In distribution
857-932DSPW In distribution
857-951W In distribution
857-945W In distribution
857-948W In distribution
857-961IW In distribution
857-953W In distribution
857-983IW In distribution
857-990IW In distribution
857-928W In distribution
857-947W In distribution
857-952W In distribution
857-993IW In distribution
857-991IW In distribution
857-992IW In distribution
857-946W In distribution
857-922DSPW In distribution
857-956W In distribution
857-958W In distribution
857-943W In distribution
857-942W In distribution
857-994IW In distribution
857-944W In distribution
857-932W In distribution
857-941W In distribution
857-954W In distribution
857-934W In distribution
857-985IW In distribution
857-984IW In distribution
857-995IW In distribution
857-936W In distribution
857-928DW In distribution
857-981IW In distribution
857-924W In distribution
857-960IDW In distribution
857-982IW In distribution
857-970IDW In distribution
857-960IW In distribution
857-971IW In distribution
857-938W In distribution
857-922W In distribution
857-972IW In distribution
857-955W In distribution
857-980IW In distribution
857-970IW In distribution
857-951DSP Withdrawn
857-994IDSPW Withdrawn
857-997I Withdrawn
857-948 Withdrawn
857-962IDW Withdrawn
857-958D Withdrawn
857-942DSP Withdrawn
857-983IDW Withdrawn
857-997IDSP Withdrawn
857-982 Withdrawn
857-949 Withdrawn
857-945 Withdrawn
857-928 Withdrawn
857-971ID Withdrawn
857-924D Withdrawn
857-943A Withdrawn
857-946D Withdrawn
857-991IDW Withdrawn
857-988IW Withdrawn
857-945DW Withdrawn
857-972 Withdrawn
857-928D Withdrawn
857-934 Withdrawn
857-960W Withdrawn
857-986I Withdrawn
857-972IDW Withdrawn
857-981W Withdrawn
857-957DSP Withdrawn
857-961I Withdrawn
857-941DSP Withdrawn
857-971W Withdrawn
857-943AW Withdrawn
857-949W Withdrawn
857-951DSPW Withdrawn
857-987I Withdrawn
857-962ID Withdrawn
857-954 Withdrawn
857-991W Withdrawn
857-943 Withdrawn
857-983I Withdrawn
857-924 Withdrawn
857-953DW Withdrawn
857-946 Withdrawn
857-942DSPW Withdrawn
857-997IDSPW Withdrawn
857-941 Withdrawn
857-956D Withdrawn
857-953AW Withdrawn
857-981IDSP Withdrawn
857-993 Withdrawn
857-970W Withdrawn
857-936 Withdrawn
857-984IDSPW Withdrawn
857-962W Withdrawn
857-983ID Withdrawn
857-996I Withdrawn
857-960 Withdrawn
857-982IDSP Withdrawn
857-981 Withdrawn
857-984W Withdrawn
857-961W Withdrawn
857-992IDSPW Withdrawn
857-984IDSP Withdrawn
857-980IDSPW Withdrawn
857-996IW Withdrawn
857-952DSP Withdrawn
857-949DSP Withdrawn
857-993IDW Withdrawn
857-991 Withdrawn
857-981I Withdrawn
857-932DSP Withdrawn
857-993W Withdrawn
857-991ID Withdrawn
857-982IDSPW Withdrawn
857-959DSP Withdrawn
857-944DSPW Withdrawn
857-958 Withdrawn
857-932 Withdrawn
857-994I Withdrawn
857-942 Withdrawn
857-995IDSPW Withdrawn
857-953D Withdrawn
857-986ID Withdrawn
857-943D Withdrawn
857-990W Withdrawn
857-961IDW Withdrawn
857-952 Withdrawn
857-962 Withdrawn
857-945D Withdrawn
857-961ID Withdrawn
857-954DSP Withdrawn
857-980W Withdrawn
857-982I Withdrawn
857-971I Withdrawn
857-941DSPW Withdrawn
857-990I Withdrawn
857-985IDSPW Withdrawn
857-990IDSPW Withdrawn
857-943DW Withdrawn
857-952DSPW Withdrawn
857-998I Withdrawn
857-951 Withdrawn
857-922DSP Withdrawn
857-990IDSP Withdrawn
857-971IDW Withdrawn
857-970I Withdrawn
857-960ID Withdrawn
857-938 Withdrawn
857-992I Withdrawn
857-953 Withdrawn
857-944DSP Withdrawn
857-959 Withdrawn
857-982W Withdrawn
857-944 Withdrawn
857-949DSPW Withdrawn
857-998IW Withdrawn
857-962I Withdrawn
857-992W Withdrawn
857-957DSPW Withdrawn
857-984 Withdrawn
857-983W Withdrawn
857-938D Withdrawn
857-987IW Withdrawn
857-926 Withdrawn
857-947DSP Withdrawn
857-938DW Withdrawn
857-980IDSP Withdrawn
857-993ID Withdrawn
857-955 Withdrawn
857-997IW Withdrawn
857-953A Withdrawn
857-993I Withdrawn
857-995I Withdrawn
857-992 Withdrawn
857-956 Withdrawn
857-992IDSP Withdrawn
857-922 Withdrawn
857-948D Withdrawn
857-970 Withdrawn
857-972W Withdrawn
857-940 Withdrawn
857-955D Withdrawn
857-954DSPW Withdrawn
857-956DW Withdrawn
857-980 Withdrawn
857-985IDSP Withdrawn
857-960I Withdrawn
857-994 Withdrawn
857-947DSPW Withdrawn
857-946DW Withdrawn
857-984I Withdrawn
857-980I Withdrawn
857-959W Withdrawn
857-957 Withdrawn
857-995IDSP Withdrawn
857-990 Withdrawn
857-987IDSPW Withdrawn
857-926D Withdrawn
857-987IDSP Withdrawn
857-971 Withdrawn
857-985I Withdrawn
857-996IDW Withdrawn
857-986IDW Withdrawn
857-970ID Withdrawn
857-986IW Withdrawn
857-959DSPW Withdrawn
857-981IDSPW Withdrawn
857-972I Withdrawn
857-988I Withdrawn
857-936D Withdrawn
857-996ID Withdrawn
857-983 Withdrawn
857-994W Withdrawn
857-994IDSP Withdrawn
857-955DW Withdrawn
857-961 Withdrawn
857-934DW Withdrawn
857-985 Withdrawn
857-972ID Withdrawn
857-934D Withdrawn
857-991I Withdrawn
857-947 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