Rematitan®
rematitan® “LITE” ideal arches, rectangular, narrow form, with dimple Mandibular, 0.43 x 0.64 mm / 17 x 25
43manufacturers in China registered for this device type
202catalogue 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 | 2024-06-19 (version 4) |
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 |
| Distribution end date | 2024-06-19 |
Catalogue Numbers
| Catalogue number | Size | Per pack | Status |
|---|---|---|---|
| 766-161-00 | 10 | In distribution | |
| 528-041-00 | In distribution | ||
| 768-113-00 | 10 | In distribution | |
| 766-080-00 | 10 | In distribution | |
| 528-042-00 | In distribution | ||
| 768-106-01 | 50 | In distribution | |
| 766-261-00 | 10 | In distribution | |
| 766-185-00 | 10 | In distribution | |
| 768-102-01 | 50 | In distribution | |
| 768-111-01 | 50 | In distribution | |
| 766-258-00 | 10 | In distribution | |
| 768-107-01 | 50 | In distribution | |
| 766-612-00 | 10 | In distribution | |
| 766-172-00 | 10 | In distribution | |
| 766-174-00 | 10 | In distribution | |
| 766-613-00 | 10 | In distribution | |
| 768-015-00 | 3 | In distribution | |
| 766-763-00 | 10 | In distribution | |
| 766-071-00 | 10 | In distribution | |
| 766-088-00 | 10 | In distribution | |
| 766-618-00 | 10 | In distribution | |
| 768-120-00 | 10 | In distribution | |
| 766-764-00 | 10 | In distribution | |
| 766-089-00 | 10 | In distribution | |
| 766-631-00 | 10 | In distribution | |
| 766-085-00 | 10 | In distribution | |
| 766-094-00 | In distribution | ||
| 768-105-01 | 50 | In distribution | |
| 768-016-00 | 3 | In distribution | |
| 766-762-00 | 10 | In distribution | |
| 766-607-00 | 10 | In distribution | |
| 766-075-00 | 10 | In distribution | |
| 766-259-00 | 10 | In distribution | |
| 766-168-00 | 10 | In distribution | |
| 768-117-00 | 10 | In distribution | |
| 766-604-00 | 10 | In distribution | |
| 768-021-00 | 3 | In distribution | |
| 768-112-00 | 10 | In distribution | |
| 766-176-00 | 10 | In distribution | |
| 766-184-00 | 10 | In distribution | |
| 766-082-01 | 50 | In distribution | |
| 768-110-00 | 10 | In distribution | |
| 766-251-00 | 10 | In distribution | |
| 766-058-00 | 10 | In distribution | |
| 766-014-00 | 10 | In distribution | |
| 766-070-00 | 10 | In distribution | |
| 766-632-00 | 10 | In distribution | |
| 766-067-00 | 10 | In distribution | |
| 766-019-00 | 10 | In distribution | |
| 528-050-00 | In distribution | ||
| 768-105-00 | 10 | In distribution | |
| 766-633-00 | 10 | In distribution | |
| 766-160-00 | 10 | In distribution | |
| 768-023-00 | 3 | In distribution | |
| 768-018-00 | 3 | In distribution | |
| 766-173-00 | 10 | In distribution | |
| 766-066-00 | 10 | In distribution | |
| 766-162-00 | 10 | In distribution | |
| 766-164-00 | 10 | In distribution | |
| 768-101-01 | 50 | In distribution | |
| 766-081-01 | 50 | In distribution | |
| 768-103-01 | 50 | In distribution | |
| 766-611-00 | 10 | In distribution | |
| 766-085-01 | 50 | In distribution | |
| 766-606-00 | 10 | In distribution | |
| 766-256-00 | 10 | In distribution | |
| 766-059-00 | 10 | In distribution | |
| 766-087-00 | 10 | In distribution | |
| 766-069-00 | 10 | In distribution | |
| 766-766-00 | 10 | In distribution | |
| 766-187-00 | 10 | In distribution | |
| 766-181-00 | 10 | In distribution | |
| 768-107-00 | 10 | In distribution | |
| 768-114-00 | 10 | In distribution | |
| 768-102-00 | 10 | In distribution | |
| 768-106-00 | 10 | In distribution | |
| 766-169-00 | 10 | In distribution | |
| 766-076-00 | 10 | In distribution | |
| 766-077-00 | 10 | In distribution | |
| 768-108-00 | 10 | In distribution | |
| 766-032-00 | 10 | In distribution | |
| 766-614-00 | 10 | In distribution | |
| 766-034-00 | 10 | In distribution | |
| 766-090-00 | 10 | In distribution | |
| 766-095-00 | In distribution | ||
| 766-177-00 | 10 | In distribution | |
| 766-074-00 | 10 | In distribution | |
| 766-619-00 | 10 | In distribution | |
| 768-022-00 | 3 | In distribution | |
| 768-103-00 | 10 | In distribution | |
| 528-040-50 | In distribution | ||
| 766-083-01 | 50 | In distribution | |
| 768-104-01 | 50 | In distribution | |
| 766-253-00 | 10 | In distribution | |
| 766-088-01 | 50 | In distribution | |
| 766-063-00 | 10 | In distribution | |
| 768-118-00 | 10 | In distribution | |
| 766-196-00 | In distribution | ||
| 766-600-00 | 10 | In distribution | |
| 528-043-00 | In distribution | ||
| 766-061-00 | 10 | In distribution | |
| 766-171-00 | 10 | In distribution | |
| 768-115-00 | 10 | In distribution | |
| 766-079-00 | 10 | In distribution | |
| 768-014-00 | 3 | In distribution | |
| 766-039-00 | 10 | In distribution | |
| 766-765-00 | 10 | In distribution | |
| 766-179-00 | 10 | In distribution | |
| 768-119-00 | 10 | In distribution | |
| 766-093-00 | 10 | In distribution | |
| 766-082-00 | 10 | In distribution | |
| 766-084-00 | 10 | In distribution | |
| 768-020-00 | 3 | In distribution | |
| 766-257-00 | 10 | In distribution | |
| 766-263-00 | 10 | In distribution | |
| 768-017-00 | 3 | In distribution | |
| 768-111-00 | 10 | In distribution | |
| 766-264-00 | 10 | In distribution | |
| 766-083-00 | 10 | In distribution | |
| 766-260-00 | 10 | In distribution | |
| 766-620-00 | 10 | In distribution | |
| 766-092-00 | 10 | In distribution | |
| 766-608-00 | 10 | In distribution | |
| 766-163-00 | 10 | In distribution | |
| 768-110-01 | 50 | In distribution | |
| 766-089-01 | 50 | In distribution | |
| 766-036-00 | 10 | In distribution | |
| 766-602-00 | 10 | In distribution | |
| 768-104-00 | 10 | In distribution | |
| 766-250-00 | 10 | In distribution | |
| 766-761-00 | 10 | In distribution | |
| 766-033-00 | 10 | In distribution | |
| 766-090-01 | 50 | In distribution | |
| 766-060-00 | 10 | In distribution | |
| 766-167-00 | 10 | In distribution | |
| 768-121-00 | 10 | In distribution | |
| 766-015-00 | 10 | In distribution | |
| 766-605-00 | 10 | In distribution | |
| 768-116-00 | 10 | In distribution | |
| 766-262-00 | 10 | In distribution | |
| 766-170-00 | 10 | In distribution | |
| 766-166-00 | 10 | In distribution | |
| 768-100-01 | 50 | In distribution | |
| 766-037-00 | 10 | In distribution | |
| 768-101-00 | 10 | In distribution | |
| 528-039-50 | In distribution | ||
| 766-629-00 | 10 | In distribution | |
| 766-609-00 | 10 | In distribution | |
| 766-091-01 | 50 | In distribution | |
| 766-178-00 | 10 | In distribution | |
| 766-081-00 | 10 | In distribution | |
| 766-760-00 | 10 | In distribution | |
| 768-109-01 | 50 | In distribution | |
| 768-100-00 | 10 | In distribution | |
| 766-188-00 | 10 | In distribution | |
| 766-180-00 | 10 | In distribution | |
| 766-616-00 | 10 | In distribution | |
| 768-108-01 | 50 | In distribution | |
| 766-018-00 | 10 | In distribution | |
| 766-252-00 | 10 | In distribution | |
| 766-078-00 | 10 | In distribution | |
| 766-065-00 | 10 | In distribution | |
| 766-072-00 | 10 | In distribution | |
| 766-080-01 | 50 | In distribution | |
| 766-073-00 | 10 | In distribution | |
| 766-617-00 | 10 | In distribution | |
| 766-062-00 | 10 | In distribution | |
| 766-091-00 | 10 | In distribution | |
| 766-254-00 | 10 | In distribution | |
| 766-186-00 | 10 | In distribution | |
| 766-086-00 | 10 | In distribution | |
| 766-182-00 | 10 | In distribution | |
| 766-183-00 | 10 | In distribution | |
| 766-084-01 | 50 | In distribution | |
| 766-601-00 | 10 | In distribution | |
| 768-019-00 | 3 | In distribution | |
| 766-165-00 | 10 | In distribution | |
| 768-109-00 | 10 | In distribution | |
| 766-064-00 | 10 | In distribution | |
| 766-603-00 | 10 | In distribution | |
| 766-610-00 | 10 | In distribution | |
| 766-255-00 | 10 | In distribution | |
| 766-068-00 | 10 | In distribution | |
| 766-175-00 | 10 | In distribution | |
| 766-615-00 | 10 | In distribution | |
| 766-272-00 | 10 | Withdrawn | |
| 528-044-00 | Withdrawn | ||
| 766-271-00 | 10 | Withdrawn | |
| 766-280-00 | 10 | Withdrawn | |
| 766-278-00 | 10 | Withdrawn | |
| 766-283-00 | 10 | Withdrawn | |
| 766-275-00 | 10 | Withdrawn | |
| 766-274-00 | 10 | Withdrawn | |
| 766-285-00 | 10 | Withdrawn | |
| 766-282-00 | 10 | Withdrawn | |
| 766-284-00 | 10 | Withdrawn | |
| 766-276-00 | 10 | Withdrawn | |
| 766-273-00 | 10 | Withdrawn | |
| 766-281-00 | 10 | Withdrawn | |
| 766-270-00 | 10 | Withdrawn | |
| 766-279-00 | 10 | Withdrawn | |
| 766-277-00 | 10 | Withdrawn |
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.