Therma-Ti D

Wire Therma TI D Lower 016X022 W/Dimple Long Modified IND 10/PK

Registry build 21.09.26
43manufacturers in China registered for this device type
294catalogue 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 D
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 2020-06-18 (version 5)

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
Storage Storage environment temperature up to 38 °C; Storage environment humidity 0 to 60 % RH
Distribution end date 2019-06-11

Catalogue Numbers

Catalogue numbers for Therma-Ti D
Catalogue number Size Status
857-365IDSP Withdrawn
857-365IDSPW Withdrawn
857-338DSPW Withdrawn
857-255 Withdrawn
857-356M Withdrawn
857-365I Withdrawn
857-360I Withdrawn
857-264 Withdrawn
857-353DSPW Withdrawn
857-344W Withdrawn
857-340W Withdrawn
857-346 Withdrawn
857-367W Withdrawn
857-363W Withdrawn
857-356IDSP Withdrawn
857-243W Withdrawn
857-366DW Withdrawn
857-366I Withdrawn
857-333DSP Withdrawn
857-263W Withdrawn
857-252PW Withdrawn
857-264LSPW Withdrawn
857-251W Withdrawn
857-272LSPW Withdrawn
857-356DSP Withdrawn
857-266LSPW Withdrawn
857-368 Withdrawn
857-366IDW Withdrawn
857-361IW Withdrawn
857-368IDSP Withdrawn
857-342DSPW Withdrawn
857-253 Withdrawn
857-255W Withdrawn
857-362 Withdrawn
857-356W Withdrawn
857-366W Withdrawn
857-340 Withdrawn
857-273LSP Withdrawn
857-362I Withdrawn
857-243 Withdrawn
857-336DSP Withdrawn
857-344IDSP Withdrawn
857-248PW Withdrawn
857-333W Withdrawn
857-364DSPW Withdrawn
857-344I Withdrawn
857-271 Withdrawn
857-340IW Withdrawn
857-250PW Withdrawn
857-364DSP Withdrawn
857-360W Withdrawn
857-275LSPW Withdrawn
857-365DSP Withdrawn
857-342MW Withdrawn
857-365IW Withdrawn
857-358IW Withdrawn
857-263LSPW Withdrawn
857-363IW Withdrawn
857-348DSP Withdrawn
857-348IW Withdrawn
857-364IDSP Withdrawn
857-362M Withdrawn
857-346I Withdrawn
857-356 Withdrawn
857-341W Withdrawn
857-266 Withdrawn
857-358DSPW Withdrawn
857-345DSPW Withdrawn
857-271LSP Withdrawn
857-358 Withdrawn
857-367IDSPW Withdrawn
857-268W Withdrawn
857-368DSP Withdrawn
857-334DW Withdrawn
857-343I Withdrawn
857-246 Withdrawn
857-336DSPW Withdrawn
857-343IDSPW Withdrawn
857-342MD Withdrawn
857-345 Withdrawn
857-336I Withdrawn
857-363I Withdrawn
857-348IDSPW Withdrawn
857-354DW Withdrawn
857-363IDSP Withdrawn
857-253PW Withdrawn
857-354W Withdrawn
857-347DSPW Withdrawn
857-273LSPW Withdrawn
857-364 Withdrawn
857-250 Withdrawn
857-254W Withdrawn
857-353 Withdrawn
857-334D Withdrawn
857-334I Withdrawn
857-342DSP Withdrawn
857-348IDSP Withdrawn
857-360IW Withdrawn
857-272W Withdrawn
857-344DSPW Withdrawn
857-268LSP Withdrawn
857-268 Withdrawn
857-266LSP Withdrawn
857-365DSPW Withdrawn
857-270LSP Withdrawn
857-361I Withdrawn
857-333IW Withdrawn
857-362IW Withdrawn
857-342M Withdrawn
857-253W Withdrawn
857-336M Withdrawn
857-366D Withdrawn
857-244 Withdrawn
857-362DSP Withdrawn
857-348I Withdrawn
857-345IW Withdrawn
857-356IW Withdrawn
857-271W Withdrawn
857-360DW Withdrawn
857-252 Withdrawn
857-343DSP Withdrawn
857-367IDSP Withdrawn
857-274LSP Withdrawn
857-342I Withdrawn
857-274W Withdrawn
857-345I Withdrawn
857-361DSP Withdrawn
857-343W Withdrawn
857-341IDSPW Withdrawn
857-358IDSP Withdrawn
857-368IW Withdrawn
857-336IDSP Withdrawn
857-361IDSP Withdrawn
857-340DW Withdrawn
857-347DSP Withdrawn
857-254PW Withdrawn
857-274LSPW Withdrawn
857-362MDW Withdrawn
857-362W Withdrawn
857-342IDSPW Withdrawn
857-368W Withdrawn
857-275 Withdrawn
857-334IW Withdrawn
857-361IDSPW Withdrawn
857-364IW Withdrawn
857-344DSP Withdrawn
857-333 Withdrawn
857-255PW Withdrawn
857-343IW Withdrawn
857-345IDSPW Withdrawn
857-272 Withdrawn
857-345W Withdrawn
857-252W Withdrawn
857-336MD Withdrawn
857-263LSP Withdrawn
857-356MW Withdrawn
857-338 Withdrawn
857-353IDSPW Withdrawn
857-246W Withdrawn
857-354D Withdrawn
857-338I Withdrawn
857-367DSP Withdrawn
857-340ID Withdrawn
857-340D Withdrawn
857-358I Withdrawn
857-336 Withdrawn
857-353IDSP Withdrawn
857-342W Withdrawn
857-346ID Withdrawn
857-273 Withdrawn
857-347IDSP Withdrawn
857-275W Withdrawn
857-364I Withdrawn
857-341 Withdrawn
857-364W Withdrawn
857-343 Withdrawn
857-334 Withdrawn
857-338IDSP Withdrawn
857-360ID Withdrawn
857-246PW Withdrawn
857-361 Withdrawn
857-264LSP Withdrawn
857-334ID Withdrawn
857-354 Withdrawn
857-358IDSPW Withdrawn
857-333IDSP Withdrawn
857-340IDW Withdrawn
857-254 Withdrawn
857-338IDSPW Withdrawn
857-244PW Withdrawn
857-347W Withdrawn
857-358DSP Withdrawn
857-344 Withdrawn
857-353W Withdrawn
857-333DSPW Withdrawn
857-345IDSP Withdrawn
857-342IW Withdrawn
857-354IW Withdrawn
857-342MDW Withdrawn
857-356MD Withdrawn
857-334IDW Withdrawn
857-346D Withdrawn
857-336MW Withdrawn
857-362MW Withdrawn
857-365 Withdrawn
857-358W Withdrawn
857-356MDW Withdrawn
857-345DSP Withdrawn
857-361DSPW Withdrawn
857-271LSPW Withdrawn
857-346W Withdrawn
857-353I Withdrawn
857-363DSP Withdrawn
857-336MDW Withdrawn
857-363DSPW Withdrawn
857-248W Withdrawn
857-340I Withdrawn
857-363IDSPW Withdrawn
857-360 Withdrawn
857-364IDSPW Withdrawn
857-362DSPW Withdrawn
857-346IDW Withdrawn
857-348DSPW Withdrawn
857-360D Withdrawn
857-347 Withdrawn
857-275LSP Withdrawn
857-367IW Withdrawn
857-263 Withdrawn
857-356IDSPW Withdrawn
857-368DSPW Withdrawn
857-338IW Withdrawn
857-338W Withdrawn
857-248 Withdrawn
857-367I Withdrawn
857-348 Withdrawn
857-244W Withdrawn
857-365W Withdrawn
857-347I Withdrawn
857-363 Withdrawn
857-362IDSPW Withdrawn
857-344IW Withdrawn
857-347IW Withdrawn
857-268LSPW Withdrawn
857-360IDW Withdrawn
857-243PW Withdrawn
857-347IDSPW Withdrawn
857-251PW Withdrawn
857-273W Withdrawn
857-366 Withdrawn
857-366ID Withdrawn

Showing 250 of 294 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