OSE

Thermal Activated Reverse Curve Super Elastic Nickel Titanium Archwires .019 x .025 Upper

Registry build 21.09.26
43manufacturers in China registered for this device type
216catalogue 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 OSE
Listed by Orthodontic Supply & Equipment Co., Inc., United States
FDA product code DZC
Device type Wire, Orthodontic
Device class Class 1
Regulation 21 CFR 872.5410
Establishment Repacker / relabeller
Premarket notification Exempt
Record published 2020-04-29

Specifications

Specifications
MRI safety Labeling does not contain MRI Safety Information
Single use Yes
Latex Contains natural rubber latex
Label carries lot or batch number

Catalogue Numbers

Catalogue numbers for OSE
Catalogue number Size Status
0255-004 In distribution
0250-090 In distribution
0258-090 In distribution
4826-314 In distribution
0250-P In distribution
0251-060 In distribution
0176-01A In distribution
0250-A In distribution
4999-513 In distribution
4999-515A In distribution
0178-050 In distribution
0263-T In distribution
0178-025 In distribution
0827-016 In distribution
0251-068 In distribution
0255-D In distribution
0927-600 In distribution
0176-020 In distribution
4999-542 In distribution
0176-120 In distribution
0251-I In distribution
0827-014 In distribution
0258-200 In distribution
0254-A In distribution
0251-E In distribution
0176-130 In distribution
0250-010 In distribution
0205-000 In distribution
0189-130 In distribution
4826-320A In distribution
0255-C In distribution
0178-220 In distribution
0251-A In distribution
0176-110 In distribution
4999-514A In distribution
4826-214A In distribution
0827-140 In distribution
0127-G In distribution
0250-100 In distribution
5530-408 In distribution
0264-E In distribution
0827-160 In distribution
0251-130 In distribution
4826-218A In distribution
0178-210 In distribution
0178-060 In distribution
0178-070 In distribution
4826-220A In distribution
0178-760 In distribution
0178-080 In distribution
0251-170 In distribution
0255-000 In distribution
0250-M In distribution
0176-11A In distribution
0178-245 In distribution
0255-A In distribution
0258-050 In distribution
0178-550 In distribution
5530-404 In distribution
0255-B In distribution
4999-514 In distribution
0176-03A In distribution
0178-730 In distribution
0250-T In distribution
0264-C In distribution
4999-512 In distribution
0251-030 In distribution
4999-540A In distribution
0176-140 In distribution
0258-100 In distribution
4826-216A In distribution
0927-400 In distribution
0176-10A In distribution
4826-320 In distribution
0250-190 In distribution
0827-180 In distribution
0927-100 In distribution
4999-513A In distribution
0176-12A In distribution
5530-406 In distribution
4999-542A In distribution
0236-S In distribution
4826-220 In distribution
0263-R In distribution
0264-K In distribution
0178-510 In distribution
0927-500 In distribution
4826-316 In distribution
0183-100 In distribution
0189-100 In distribution
0178-545 In distribution
0178-580 In distribution
0183-090 In distribution
0258-020 In distribution
4999-544 In distribution
4999-541A In distribution
0236-P In distribution
0827-013 In distribution
0927-050 In distribution
0250-200 In distribution
4999-512A In distribution
0178-725 In distribution
0263-P In distribution
4999-511A In distribution
0251-070 In distribution
4999-515 In distribution
0254-C In distribution
0251-125 In distribution
0263-M In distribution
0927-060 In distribution
0178-250 In distribution
0251-165 In distribution
0178-780 In distribution
0264-G In distribution
4999-544A In distribution
0236-X In distribution
0255-001 In distribution
0250-050 In distribution
4999-540 In distribution
0178-570 In distribution
0178-270 In distribution
0178-240 In distribution
0927-040 In distribution
0176-000 In distribution
4999-511 In distribution
4999-545 In distribution
4826-316A In distribution
4999-541 In distribution
0264-I In distribution
0176-14A In distribution
0250-B In distribution
4826-318 In distribution
0254-D In distribution
0255-E In distribution
0250-020 In distribution
0178-720 In distribution
0178-560 In distribution
0204-E In distribution
0927-200 In distribution
0178-280 In distribution
0176-00A In distribution
0178-525 In distribution
0236-V In distribution
0176-13A In distribution
0251-080 In distribution
4826-216 In distribution
5530-403 In distribution
0927-010 In distribution
4826-214 In distribution
0178-260 In distribution
0236-N In distribution
4999-543 In distribution
0258-B In distribution
4826-314A In distribution
0927-030 In distribution
0927-300 In distribution
0178-530 In distribution
0255-002 In distribution
0178-225 In distribution
0251-C In distribution
4999-510A In distribution
0178-230 In distribution
0176-040 In distribution
0251-025 In distribution
0178-045 In distribution
0176-030 In distribution
0178-010 In distribution
0178-770 In distribution
0258-A In distribution
0176-02A In distribution
0254-B In distribution
0250-000 In distribution
0236-T In distribution
0178-710 In distribution
5530-405 In distribution
0178-540 In distribution
0127-B In distribution
0176-100 In distribution
0264-A In distribution
0258-000 In distribution
0251-180 In distribution
0127-A In distribution
4826-218 In distribution
0183-240 In distribution
0251-168 In distribution
0178-750 In distribution
0251-G In distribution
0178-040 In distribution
4999-543A In distribution
0178-020 In distribution
0178-520 In distribution
0827-018 In distribution
4999-545A In distribution
0183-110 In distribution
0258-010 In distribution
0127-H In distribution
5530-407 In distribution
0176-010 In distribution
0250-R In distribution
0183-120 In distribution
5530-402 In distribution
0178-745 In distribution
4826-318A In distribution
0183-A In distribution
0176-04A In distribution
0255-003 In distribution
4999-510 In distribution
0178-740 In distribution
0178-030 In distribution
0827-130 In distribution
0251-065 In distribution
0251-160 In distribution
5530-401 In distribution
0251-K In distribution
0927-020 In distribution
0258-190 In distribution

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