Orthosource
Super Elastic DIMPLE Nickel Titanium Natural Arch WIDE .018 X .025 Lower 10pc
43manufacturers in China registered for this device type
309catalogue 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.
| 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
| Listed by | Orthosource, Inc., United States |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Premarket notification | Exempt |
| Record published | 2022-10-29 |
| Record revised | 2022-11-04 (version 2) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Label carries | lot or batch number, expiry date |
| Packaging | 100 pk of 10, pack of 10, 100 pcs of 10 |
| Distribution end date | 2022-11-02 |
| UDI direct marking | Exempt |
Catalogue Numbers
| Catalogue number | Size | Status |
|---|---|---|
| 618-008W | In distribution | |
| 628-718W | In distribution | |
| 638-079 | In distribution | |
| 618-118 | In distribution | |
| 615-625 | In distribution | |
| 618-017W | In distribution | |
| 618-221W | In distribution | |
| 618-068 | In distribution | |
| 628-116 | In distribution | |
| 615-504 | In distribution | |
| 628-116W | In distribution | |
| 618-079 | In distribution | |
| 615-624 | In distribution | |
| 615-204 | In distribution | |
| 618-073 | In distribution | |
| 618-078 | In distribution | |
| 615-503 | In distribution | |
| 638-082 | In distribution | |
| 638-074 | In distribution | |
| 628-114 | In distribution | |
| 628-519W | In distribution | |
| 628-517 | In distribution | |
| 638-076 | In distribution | |
| 618-069 | In distribution | |
| 628-112W | In distribution | |
| 628-312 | In distribution | |
| 635-204 | In distribution | |
| 615-522 | In distribution | |
| 635-205 | In distribution | |
| 628-717W | In distribution | |
| 615-202 | In distribution | |
| 628-120W | In distribution | |
| 618-020 | In distribution | |
| 628-521 | In distribution | |
| 618-006 | In distribution | |
| 618-521 | In distribution | |
| 638-073 | In distribution | |
| 628-716W | In distribution | |
| 618-017 | In distribution | |
| 618-004 | In distribution | |
| 638-075 | In distribution | |
| 628-516 | In distribution | |
| 615-505 | In distribution | |
| 638-085 | In distribution | |
| 628-314 | In distribution | |
| 628-721 | In distribution | |
| 628-717 | In distribution | |
| 628-721W | In distribution | |
| 618-204 | In distribution | |
| 618-112 | In distribution | |
| 635-221 | In distribution | |
| 618-514 | In distribution | |
| 615-605 | In distribution | |
| 635-126 | In distribution | |
| 618-075 | In distribution | |
| 638-072 | In distribution | |
| 635-123 | In distribution | |
| 618-218W | In distribution | |
| 615-623 | In distribution | |
| 635-225 | In distribution | |
| 638-081 | In distribution | |
| 618-518 | In distribution | |
| 628-316W | In distribution | |
| 618-008 | In distribution | |
| 615-121 | In distribution | |
| 618-216 | In distribution | |
| 628-320 | In distribution | |
| 618-216W | In distribution | |
| 628-714W | In distribution | |
| 638-078 | In distribution | |
| 618-208W | In distribution | |
| 618-018W | In distribution | |
| 615-523 | In distribution | |
| 638-086 | In distribution | |
| 628-120 | In distribution | |
| 618-071 | In distribution | |
| 628-114W | In distribution | |
| 618-016 | In distribution | |
| 635-104 | In distribution | |
| 615-126 | In distribution | |
| 615-105 | In distribution | |
| 635-124 | In distribution | |
| 615-221 | In distribution | |
| 628-716 | In distribution | |
| 635-202 | In distribution | |
| 615-626 | In distribution | |
| 628-112 | In distribution | |
| 618-074 | In distribution | |
| 615-102 | In distribution | |
| 618-019W | In distribution | |
| 615-122 | In distribution | |
| 638-083 | In distribution | |
| 618-076 | In distribution | |
| 635-105 | In distribution | |
| 618-016W | In distribution | |
| 618-086 | In distribution | |
| 618-202 | In distribution | |
| 628-312W | In distribution | |
| 635-226 | In distribution | |
| 615-521 | In distribution | |
| 638-080 | In distribution | |
| 615-524 | In distribution | |
| 618-116 | In distribution | |
| 618-204W | In distribution | |
| 618-083 | In distribution | |
| 635-122 | In distribution | |
| 628-320W | In distribution | |
| 618-218 | In distribution | |
| 618-021W | In distribution | |
| 618-072 | In distribution | |
| 618-112W | In distribution | |
| 618-085 | In distribution | |
| 618-219W | In distribution | |
| 618-120 | In distribution | |
| 628-514 | In distribution | |
| 618-208 | In distribution | |
| 615-205 | In distribution | |
| 618-002 | In distribution | |
| 618-182 | In distribution | |
| 628-518 | In distribution | |
| 638-071 | In distribution | |
| 615-621 | In distribution | |
| 615-104 | In distribution | |
| 618-519 | In distribution | |
| 618-070 | In distribution | |
| 618-081 | In distribution | |
| 638-070 | In distribution | |
| 618-217 | In distribution | |
| 615-123 | In distribution | |
| 628-118W | In distribution | |
| 635-125 | In distribution | |
| 618-180 | In distribution | |
| 618-112W-100 | In distribution | |
| 635-102 | In distribution | |
| 618-214W | In distribution | |
| 618-217W | In distribution | |
| 628-719W | In distribution | |
| 615-622 | In distribution | |
| 615-602 | In distribution | |
| 635-103 | In distribution | |
| 628-514W | In distribution | |
| 615-526 | In distribution | |
| 618-020W | In distribution | |
| 618-077 | In distribution | |
| 628-519 | In distribution | |
| 638-077 | In distribution | |
| 618-206W | In distribution | |
| 628-718 | In distribution | |
| 618-114 | In distribution | |
| 618-206 | In distribution | |
| 618-112-100 | In distribution | |
| 628-118 | In distribution | |
| 618-004W | In distribution | |
| 618-087 | In distribution | |
| 638-068 | In distribution | |
| 618-202W | In distribution | |
| 615-502 | In distribution | |
| 638-069 | In distribution | |
| 618-221 | In distribution | |
| 618-219 | In distribution | |
| 618-214 | In distribution | |
| 628-314W | In distribution | |
| 618-516 | In distribution | |
| 635-121 | In distribution | |
| 618-018 | In distribution | |
| 618-084 | In distribution | |
| 615-203 | In distribution | |
| 618-014 | In distribution | |
| 628-318 | In distribution | |
| 615-604 | In distribution | |
| 628-517W | In distribution | |
| 618-082 | In distribution | |
| 618-002W | In distribution | |
| 635-203 | In distribution | |
| 615-525 | In distribution | |
| 628-518W | In distribution | |
| 628-318W | In distribution | |
| 628-714 | In distribution | |
| 618-088 | In distribution | |
| 638-088 | In distribution | |
| 628-719 | In distribution | |
| 628-516W | In distribution | |
| 618-021 | In distribution | |
| 628-316 | In distribution | |
| 615-103 | In distribution | |
| 618-220 | In distribution | |
| 638-089 | In distribution | |
| 615-603 | In distribution | |
| 628-521W | In distribution | |
| 618-006W | In distribution | |
| 618-019 | In distribution | |
| 618-517 | In distribution | |
| 638-084 | In distribution | |
| 618-220W | In distribution | |
| 618-014W | In distribution | |
| 618-521W | Withdrawn | |
| 618-318W | Withdrawn | |
| 615-018 | Withdrawn | |
| 618-416 | Withdrawn | |
| 618-210 | Withdrawn | |
| 619-012 | Withdrawn | |
| 618-314W | Withdrawn | |
| 618-519W-100 | Withdrawn | |
| 618-518W-100 | Withdrawn | |
| 615-226 | Withdrawn | |
| 618-320W | Withdrawn | |
| 618-716-100 | Withdrawn | |
| 618-011 | Withdrawn | |
| 618-718W-100 | Withdrawn | |
| 618-719W | Withdrawn | |
| 618-718 | Withdrawn | |
| 618-721W-100 | Withdrawn | |
| 618-714 | Withdrawn | |
| 618-717 | Withdrawn | |
| 618-716 | Withdrawn | |
| 618-320-100 | Withdrawn | |
| 618-320W-100 | Withdrawn | |
| 618-312W | Withdrawn | |
| 618-316-100 | Withdrawn | |
| 618-516W-100 | Withdrawn | |
| 618-318-100 | Withdrawn | |
| 614-028 | Withdrawn | |
| 618-318 | Withdrawn | |
| 618-012 | Withdrawn | |
| 618-714-100 | Withdrawn | |
| 618-116W-100 | Withdrawn | |
| 615-222 | Withdrawn | |
| 618-316W | Withdrawn | |
| 618-116-100 | Withdrawn | |
| 618-719 | Withdrawn | |
| 615-020 | Withdrawn | |
| 615-016 | Withdrawn | |
| 615-223 | Withdrawn | |
| 618-721 | Withdrawn | |
| 618-320 | Withdrawn | |
| 618-514W-100 | Withdrawn | |
| 618-418 | Withdrawn | |
| 618-517W-100 | Withdrawn | |
| 618-518W | Withdrawn | |
| 615-014 | Withdrawn | |
| 618-118W | Withdrawn | |
| 618-120W | Withdrawn | |
| 635-222 | Withdrawn | |
| 618-516W | Withdrawn | |
| 618-721-100 | Withdrawn | |
| 618-114W | Withdrawn | |
| 615-224 | Withdrawn | |
| 635-223 | Withdrawn | |
| 618-120-100 | Withdrawn | |
| 248-045 | Withdrawn |
Showing 250 of 300 catalogue numbers.
Same 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.