Dentaflex®
dentaflex® wire on coils, round, 6-strand “co-axial”, super spring hard Maxillary, ø 0.38 mm / 15
43manufacturers in China registered for this device type
48catalogue 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 | Dentaurum GmbH & Co. KG, Germany |
|---|---|
| FDA product code | DZC |
| Device type | Wire, Orthodontic |
| Device class | Class 1 |
| Regulation | 21 CFR 872.5410 |
| Establishment | Manufacturer, Exporter |
| 510(k) | K935140 |
| Record published | 2016-09-15 |
| Record revised | 2018-07-06 (version 3) |
Specifications
| MRI safety | Labeling does not contain MRI Safety Information |
|---|---|
| Single use | Yes |
| Prescription | Prescription only |
| Label carries | lot or batch number |
| Storage | Special storage condition: No special storage conditions required |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 545-745-00 | 10 | In distribution | |
| 766-123-00 | 10 | In distribution | |
| 545-638-01 | In distribution | ||
| 766-201-00 | 10 | In distribution | |
| 766-131-00 | 10 | In distribution | |
| 766-400-00 | 10 | In distribution | |
| 766-122-00 | 10 | In distribution | |
| 766-132-01 | 50 | In distribution | |
| 766-401-00 | 10 | In distribution | |
| 766-125-00 | 10 | In distribution | |
| 766-121-01 | 50 | In distribution | |
| 766-103-00 | 10 | In distribution | |
| 766-120-01 | 50 | In distribution | |
| 545-645-01 | In distribution | ||
| 766-124-00 | 10 | In distribution | |
| 766-203-00 | 10 | In distribution | |
| 766-200-00 | 10 | In distribution | |
| 766-101-00 | 10 | In distribution | |
| 766-130-00 | 10 | In distribution | |
| 766-132-00 | 10 | In distribution | |
| 766-400-01 | 50 | In distribution | |
| 766-200-01 | 50 | In distribution | |
| 766-204-00 | 10 | In distribution | |
| 545-738-00 | 10 | In distribution | |
| 766-301-00 | 10 | In distribution | |
| 766-105-00 | 10 | In distribution | |
| 766-100-01 | 50 | In distribution | |
| 766-104-00 | 10 | In distribution | |
| 766-300-00 | 10 | In distribution | |
| 766-201-01 | 50 | In distribution | |
| 766-133-01 | 50 | In distribution | |
| 766-771-00 | 10 | In distribution | |
| 766-205-00 | 10 | In distribution | |
| 545-750-00 | 10 | In distribution | |
| 545-738-01 | In distribution | ||
| 766-121-00 | 10 | In distribution | |
| 766-401-01 | 50 | In distribution | |
| 766-133-00 | 10 | In distribution | |
| 766-100-00 | 10 | In distribution | |
| 766-101-01 | 50 | In distribution | |
| 766-122-01 | 50 | In distribution | |
| 766-123-01 | 50 | In distribution | |
| 766-301-01 | 50 | In distribution | |
| 766-300-01 | 50 | In distribution | |
| 545-645-00 | 10 | In distribution | |
| 766-120-00 | 10 | In distribution | |
| 545-745-01 | In distribution | ||
| 545-638-00 | 10 | In distribution |
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.